cobas e 411 analyzer

User Training Guide

 cobas e 411 analyzer

Revision history

Manual Version Template Version Revision date Changes

1.0 3.0

Edition notice cobas e 411 analyzer User Training Guide

Every effort has been made to ensure that all the information contained in this guide
is correct at the time of printing. However, Roche Diagnostics GmbH reserves the
right to make any changes necessary without notice as part of ongoing product
development.
Any customer modification to the instrument will render the warranty or service
agreement null and void. For warranty conditions, refer to the analyzer purchase
agreement. Contact your local Roche Diagnostics representative for further
information.
Software updates are done by Roche Diagnostics representatives.

Copyrights © 2001-2006, Roche Diagnostics GmbH. All rights reserved.

Trademarks COBAS, COBAS C, COBAS E, ELECSYS, and LIFE NEEDS ANSWERS are
trademarks of Roche.
All other trademarks are the property of their respective owners.

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cobas e 411 analyzer

Table of contents

Universal Diluent or MultiAssay (MA)

System description Part A recommendations C-12
Checklist of reagent handling C-14
1 System overview
Overview of the cobas e 411 analyzer A-3 8 Calibration concept
System components A-5 General information about calibrators C-19
Control unit A-8 Calibration kit C-20
Sample/reagent area components A-9 Overview of calibrators C-21
Consumables area components A-13 Data transfer rules C-26
Measuring area components A-17 Lot calibration and reagent pack calibration C-27
General calibration rules C-28
2 Specifications Calibration stability C-29
System specifications A-21 Reagent stability C-29
Overview of calibrators and stability C-29
3 Laboratory exercises Calibration quality criteria C-30
Exercise 1: System overview A-25 Calibration status display C-32
Exercise 2: System overview A-27 Different reason to calibrate a test C-33

9 Quality control concept

Measurement technology Part B General information about controls C-35
Overview of control types and relevancy to tests C-36
4 ECL (IA) technology Control stability C-37
Introduction B-3 Overview of control types C-38
Test principles B-4 Priorities of control target value C-38
The basic principle B-4 Control settings and consequences C-39
The measuring cell B-5
Advantages of ECL technology B-11 10 Laboratory exercises
Exercise 4: Reagent concepts C-41
5 Assay overview Exercise 5: Calibration concepts C-43
Sandwich principle B-14 Exercise 6: Quality control concepts C-46
Competitive principle B-16
Bridging principle B-18
Software description Part D
6 Laboratory exercises
Exercise 3: ECL technology, test overview, and 11 System Overview screen
principles B-21 Overview D-3
Global buttons and screens D-10
Concepts Part C 12 Workplace menu
Workplace/Test Selection D-15
7 Reagent concept Workplace/Data Review D-18
Reagent kit box labels C-3
Reagent packs C-4 13 Reagent menu
Reagent barcode label C-5 Reagent D-25
Package inserts C-6
Data transfer media C-6 14 Calibration menu
Data concept C-7 Status D-29
Reagents for cobas e 411 tests C-10 Calibrator D-35
Diluents for the cobas e 411 analyzer C-10 Install D-36
System reagents for the cobas e 411 analyzer C-11
System accessories for the cobas e 411 analyzer C-11 15 Quality Control menu
Status D-38

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Run Status D-39 Diluents G-5

Individual D-41 System reagents G-6
Cumulative D-46 System accessories G-6
Control D-47 Racks for samples, calibrators, and controls G-7
Install D-49

16 Utility menu
Laboratory exercises Part H
System D-53
User access levels D-62 22 Answers to laboratory exercises
Application D-75 Exercise 1: System overview H-3
Exercise 2: System overview H-5
17 Laboratory exercises Exercise 3: ECL technology, test overview, and
Exercise 7: Start up and routine operation D-79 principles H-7
Exercise 8: Start up and routine operation D-81 Exercise 4: Reagent concepts H-9
Exercise 9: Start up and routine operation D-83 Exercise 5: Calibration concepts H-11
Exercise 10: Adding new tests to the system D-85 Exercise 6: Quality control concepts H-14
Exercise 11: Adding new tests to the system D-86 Exercise 7: Start up and routine operation H-16
Exercise 12: Calibration and quality control D-88 Exercise 8: Start up and routine operation H-17
Exercise 13: Calibration and quality control D-89 Exercise 9: Start up and routine operation H-19
Exercise 14: Calibration and quality control D-90 Exercise 10: Adding new tests to the system H-21
Exercise 15: Calibration and quality control D-91 Exercise 11: Adding new tests to the system H-22
Exercise 16: Addition routine tasks D-93 Exercise 12: Calibration and quality control H-24
Exercise 17: Addition routine tasks D-94 Exercise 13: Calibration and quality control H-25
Exercise 14: Calibration and quality control H-26
Exercise 15: Calibration and quality control H-27
Troubleshooting Part E Exercise 16: Addition routine tasks H-29
Exercise 17: Addition routine tasks H-30
18 Troubleshooting Exercise 18: Maintenance H-32
Introduction E-99
List of data alarms E-100
Data alarms: general E-101
Notes Part I
Data alarms: controls and samples E-113
Alarm abbreviations and status conditions E-114

Maintenance Part F

19 Maintenance
Maintenance items F-117
Maintenance schedule F-123
Daily maintenance F-124
Weekly maintenance F-127
Every two weeks maintenance F-130
Every two months F-135
As needed maintenance F-140

20 Laboratory exercises
Exercise 18: Maintenance F-151

Ordering list Part G

21 Ordering list
Reagents and calibrators G-3
Controls G-5

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 System description A

1 System overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21
3 Laboratory exercises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-25
cobas e 411 analyzer 1 System overview
Overview of the cobas e 411 analyzer

System overview

Overview of the cobas e 411 analyzer

The Roche Diagnostics cobas e 411 immunoassay system is an automated, random-

access, multichannel analyzer for immunological analysis. It is designed for both
quantitative and qualitative in vitro determination of a wide range of analytes by use
of electrochemiluminescent (ECL) technology.

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Overview of the cobas e 411 analyzer

Disk system

Rack system

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System components

A USB ports B Host port

System components

The system is divided into the following main components:

o Control unit
o Sample/reagent area
o Consumables area
o Measuring area

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System components

A B C D
A Operation switch B Sample/reagent area
C Measuring area D Consumables area
E Control unit

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System components

A B C

A C-Line B A-Line
C B-Line

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Control unit

Control unit

The control unit is located at the top left of the analyzer and consists of the following
components:
o PC Pentium 4 processor without external software keyboard (numeric and a full
keyboard)
o Color touchscreen monitor
o Operating system: Microsoft Windows XP
o Connections located on the left side for:
O Data storage (flash memory, memory cards, and CD-ROMs)
O External printer
O Host interface
o User software, including a context-sensitive online Help function

B C
A Host interface B Full keyboard
C Numeric keyboard

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Sample/reagent area components

Sample/reagent area components

Sample/Reagent (S/R) probe on

disk (new)

A Sampling position

Sample/Reagent (S/R) probe on

rack, and barcode card reader

A
A Sampling position

Reagent cup open/close

mechanism on the reagent rotor

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Sample/reagent area components

Sample/reagent (S/R) probe on

pipetting position

Sample/reagent (S/R) syringe

A Sample/reagent syringe

Microbead mixer and rinse

station

A
B

A Sampling position B Rinse station

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Sample/reagent area components

Reagent rotor o Temperature controlled 20°C ± 3°C

o Accommodates up to 18 Elecsys reagent packs
o Diluent (max. of 8) and pre-treatment (max. of 9) reagent packs are not fixed
o Stand by reagent packs are possible

Barcode reader (3) o Barcode card reading station is used for calibrator and control cards (located
between sample and reagent rotor)
o Reagent barcode reader is used to scan 2-dimensional barcode label (PDF417) on
the reagent packs (located inside the reagent rotor)
One disk/30 positions)
o The barcode reader is used to scan sample IDs and the sample disk (located inside
the sample disk)

(One rack/five position)

o The barcode reader is used to scan sample IDs and rack ID numbers (located
inside the B line- sampling position)

Reagent cap/close mechanism o Automatic open/closing of the reagent packs, thus preventing evaporation of the
reagents (located on the back wall of reagent rotor)

Sample/Reagent (S/R) probe o Moves horizontally between sample and reagent rotor
o Disposable tips to avoid sample carry over
o Liquid level (by capacitance measurement)
o Clot detection (by pressure transducer)
o R1/R2 consumption: 50-80 µl dependent on test
o Microbead consumption: 30-50 µl dependent on test (located on the back left wall
in the system)

Microbead mixer o Mixing the microbeads in one slot of each reagent pack (located to the right side
of reagent rotor)

Bead mixer rinse station o Rinse station rinses the tip or bead mixer with deionized water (located below the
S/R probe and bead mixer)

Sample/Reagent (S/R) syringe o Filled with deionized water (located on the back right in the system)

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Sample/reagent area components

Sample disk flap o To protect the sample disk with samples (located above the sample disk)
(new - only for disk systems)

A Sample disk protective cover

o Be sure to lay down the sample disk protective cover before you start operation!

Rack sampler o Consists of an A-line, B-line, C-line and STAT position

o Racks can be loaded during operation (100 sample IDs in total)
o 15 racks in one time and five racks in the input/output buffer
o Tray indication light (on/off)
o Single racks cannot be removed
o If the buffer fills and there is no tray, the system issues an alarm and stops
sampling racks
Tray Tray Tray
Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication
light
B-Line

5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
tray
indication
light
STAT

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Consumables area components

Consumables area components

Tip and cup tray

o Three tips and cups tray on board (120 tips and 60 cups per each tray)
o 360 tips and 180 cups in total

Solid waste tray and liner

o Waste capacity: 1100 tips and cups

o Inventory check:
O If tray is full or liner is missing red alarm occurs
O Yellow alarm, when number of discarded disposables reaches 900
O Red alarm, when number of discarded disposables reaches 1100
O During operation the trays shakes periodically
O Exchange during operation is not possible (causes E. stop status)
o Located behind the front access door on the system

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Consumables area components

Gripper

z axis
B

A C

D
y axis

x axis

A Position 1 B Position 2
C Tray 3 D Tray 2
E Tray 1

o The gripper moves in three directions:

o X (left and right
o Y (forward and back)
o Z (up and down)
o During operation, the system starts with tips and cups from tray 1 and cup 1, 2, 3,
and so on

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Consumables area components

Cup disposal opening

A Cup disposal opening

o Cups are discarded through a cup opening (located directly to the left of the
incubator)

Pipetting station

A Pipetting station

o Five position pipetting station

o Positions 1 and 2 are used for tips
o Positions 3 and 4 are used to hold cups for diluent or pre-treatment
o Position 5 is used for sample and reagent pipetting
o Tips are discarded at the tip eject station (located to the upper left of the
incubator)

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Consumables area components

Liquid waste container

A Liquid waste container

o Up to 4 liters of waste
o A red alarms occurs if empty (triggered by a weight-sensitive mechanism
o Second alarm is issued if position is wrong (triggered by plate mechanism)
o Removal during operation causes E. stop status
o Located in front of the ProCell and CleanCell reagents

System water container

A System water container

o Removing during operation causes P. stop status

o Water requirements: < 10 µS/cm or > 0.1 mega Ohm, bacteria free
o Water consumption (approximate):
O Three liters for 250 tests
O 12 mL/cycle
o Located in front of the pipetters

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Measuring area components

Measuring area components

Incubator

o An incubator with 32 positions for assay cups in which the immunoreactions take
place
o Temperature controlled at 37°C ± 0.3°C
o Volume of cups: 200 µl
o The aspiration station is located in the right corner of the incubator (not
temperature controlled)

Sipper probe and rinse station

o Aspirates the reaction mixture

o Aspirates the ProCell and CleanCell reagents
o The sipper rinse station washes the probe with system water between
measurements
o Located to the right side of the incubator

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Measuring area components

Sipper syringe

A Sipper syringe

o Filled with deionized or distilled water

o Located directly to the right of the sample/reagent pipetter

System reagents
A B
(ProCell and CleanCell)

A Set 2 B Set 1

o One bottle contains 380 mL

o Approximately 2 mL per cycle PC/CC consumption
o Temperature controlled 28°C ± 2°C
o Allow bottle change over without interrupting operation
o When starting from Standby, the first position of set 1 is used (see the picture for
the new position)

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Measuring area components

o One bottle set PC/CC can be used, if position one is occupied from the system
reagent
o Located behind the liquid waste container

Sipper protection shield (new)

A Push here to open/close

Detection unit

o Core of the cobas e 411 analyzer

o Temperature controlled 28°C ± 0.5°C
o 42 seconds cycle time
o Comprises:
O Photomultiplier tube
O Peltier
O Flow-through measuring cell
O Magnet drive assembly
O Amplifier circuit board

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Measuring area components

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cobas e 411 analyzer 2 Specifications
System specifications

Specifications

System specifications

System o Bench top analyzer, continues random access

o Reagent pipetting technology
o Available as disk and rack systems

Throughput o Test and sample throughput up to 86 tests/hr (theoretical maximum)

Rerun/reflex function o Automatic rerun and reflex testing is not supported by the system

Name for 4000 series o cobas +letter + XXX

cobas c 311 plus e 411 O cobas+e=immunology+even numbers=immuno
O chem.+1= standalone+1=identifier for generation

Sample type o Serum, plasma, urine, others

Test principle o Heterogeneous immunoassays,

o ECL technology
o Competitive and Sandwich (Bridging) tests
o 9, 18 and 27 minute tests
o STAT sample capability 9 minute tests

Test methods o Pre-defined Elecsys assay protocols (sandwich, competitive, bridging)

Cycle time o Each cycle takes 42 seconds

Number of channels o 18 reagent disk positions maintained at a temperature of 20°C ± 3°C

Sample input/output o Load/unload capacity:

O 30 samples (disk)

O 5 samples on 15 racks
O Roche Diagnostics standard 5-position rack used for routine and STAT
samples, control, and calibration

o STAT handling
O Any unoccupied position on the sample disk, dedicated STAT port on the rack
feeder
O STAT samples are processed with priority

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cobas e 411 analyzer 2 Specifications
System specifications

Sample container types o Primary tubes: 5 to 10 mL; 16 x 100, 16 x 75, 13 x 100, 13x 75 mm
o Sample cup: 2.5 mL
o Micro cups are not allowed
o Cups on tube Cup on top of a 16 x 75/100 mm tube

Sample volume o 10 to 50 µl per test, depending on assay protocol

Sample detection o Liquid level detection and clot detection

Minimum sample volume o Primary tubes:

O 600 µl (13 mm tube)
O 1000 µl (16 mm tube)
o Sample cup:
O 200 µl (standard cup on tube)
O 150 µl with special setting

Sample barcode types o Code 128

o Codabar (NW 7)
o Interleaved 2 of 5
o Code 39

Positive reagent identification o PDF417 (2-dimensional barcode label)

Database o First database:

O 2000 tests for routine, STAT, and controls
O Manual rerun records are included
o 6 profiles for key settings
o Reagent data:
O Up to 300 reagent packs
o Parameter data
O Up to 300 reagent packs
O Up to 20 operator IDs
o Log data:
O Up to 20000 daily alarm blocks
O Up to 10 MB host communication log

Calibration o 160 calibrators can be installed by barcode card, remotely, or CD-ROM

o “Timer” and “QC failure” triggered
o 2-point lot or reagent pack calibration
o 25 calibrations/per test and level is displayed in Calibration Trace chart (50
calibrations in total)

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cobas e 411 analyzer 2 Specifications
System specifications

Quality control (QC) o 100 controls can be installed by barcode card

o 60 Elecsys tests can be assigned to each control
o Control numbers: reserved 0-63 for Roche Diagnostics (RD) controls
o Control numbers: reserved 64-78 for non-RD QCs
o Run status screen: last 500 QC results (fifo)
o Individual QC chart (fifo): up to 3 control levels and maximum 180 target values
(mean and SD) for each control level
o QC chart for accumulated QC points (fifo): up to 3 control levels, maximum 500
for numbers of accumulations include all tests

Reagent system o 300 reagent packs (fifo)

o Reagent consumption R1/R2: 50 to 80 µL per reagent dependent on test
o Microbead consumption R1/R2: 30 µl to 50 µl per test, depending on assay
protocol
o Availability on Elecsys 1010/2010 and Modular Analytics for E combinations
(additional 2D barcode on reagent pack)
o Reagent stable on the system for up to 8 weeks
o Fully compatible with all established test protocols
o Basic calibrations rules are identical to Modular Analytics for E combinations
SWA PL SW
o Reagent detection: liquid level detection
o Automatic dilution available up to 1:100

Hardware o Carryover free sample pipetting as tips only used once

o Carryover free reaction as assay cups only used once
o 32 incubator positions (37°C ± 0.3°C)
o Automatic feed - in of tips and assay cups
o Direct drain option for liquid waste
o Physical dimensions:
O Width: 1200 to 1700 mm (disk/rack system)
O Depth: 730 to 950 mm (disk/rack system)
O Height: 560 mm (without PC unit)

On-board control unit o PC Pentium 4 processor without external keyboard (numeric and a full keyboard)
and with colored 15' SVGA Touch Screen monitor
o Operating system, Microsoft Windows XP (embedded in a 512 MB compact flash
card)
o Old (Elecsys 2010) plus new (cobas) host protocol
o Online connectibility/Remote Service capabilities
o Mouse can be used as backup device

Water/waste requirements o Water requirements: < 10 µS/cm or > 0.1 mega Ohm, bacteria free
o Water consumption (approximate)
O 3 L for 250 tests
O 12 mL/cycle
o System water container capacity: 3 liters (if empty red alarms occurs)
o Liquid waste capacity (4 liters)

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2 Specifications cobas e 411 analyzer
System specifications

AssayCup/AssayTip capacity o Three assay tips/cups tray (120 tips and 60 cups per each tray)
o Waste capacity: 1100 tips and cups
o Inventory check:
O If tray is full or liner is missing: red alarm
O When number of discarded disposables reaches 900: yellow alarm
O When number of discarded disposables reaches 1100: red alarm

System reagents o Two sets of ProCell/CleanCell (PC/CC)

O If one bottle set is empty, a yellow alarm is displayed
O If both bottle sets are empty, a red alarm is displayed and the system stops
o Bottle set package contains six 380 mL bottles
o PC/CC consumption is approximately 2 mL per cycle

Temperature o Reagent disk temperature 20°C ± 3°C

o Detection unit temperature 28°C ± 0.3°C
o System reagents (ProCell and CleanCell) temperature: 28°C ± 2°C
o Incubator temperature: 37°C ± 0.3°C

Incubation system o Incubator capacity: 32 assay cups

o Volume of assay cups: 200 µL

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Exercise 1: System overview

Laboratory exercises

Exercise 1: System overview

Perform the following exercises using the cobas e 411 analyzer Training Guide as a
reference. For more detailed information, refer to the How to... chapter of the
cobas e 411 analyzer Operator’s Manual.

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Describe the main components of the cobas e 411 disk and rack analyzers

Exercises

Sample/
reagent area
Consumables
and liquid
waste area
Operation
E switch
Main circuit
breaker
(hidden)
Control unit

Measuring
F area

A B C D

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Exercise 1: System overview

STAT (Short
Turn Around
Time)
position
A B-Line
B (hidden)
A-Line
C
C-Line

D Rack sampler
circuit breaker

Quiz

Mark the correct sequence of system reagent in the figure above with a l

Position 1, 2, 3, and 4 starting on the left hand side

Position 1, 2, 3, and 4 starting on the right hand side

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Exercise 2: System overview

Exercise 2: System overview

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Classify the pictures as components of either the disk or rack system
o Be familiar of the cobas e 411 system specifications

Exercises

Sample flap

Sample/Reagent area: sampler for samples, calibrators, and controls

Tray Tray Tray

Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication
light
B-Line

5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
tray
indication
light
STAT

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Exercise 2: System overview

Quiz

Mark each of the following statements with a l if true for the cobas e 411 analyzer
specifications:

PC with touch screen and without external keyboard

Cobas host protocol do not upload the results of Calc tests

A protection cover is located on the sipper and pipetter area

Up to 15 reagent packs can be placed into the reagent rotor

Solid waste tray and liner can be not be replaced during the run

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 Measurement technology B

4 ECL (IA) technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

5 Assay overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-13
6 Laboratory exercises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-21
cobas e 411 analyzer 4 ECL (IA) technology
Introduction

ECL (IA) technology

Introduction

The advantage of electrically initiating the chemiluminescent reaction is that the

entire reaction can be precisely controlled.

E ú Electro

C ú Chemo

L ú Luminescence

I ú Immuno

A ú Assay

Most important elements/substances:

o Measuring cell
o Antigen/antibody
o Biotin
o Paramagnetic microbeads coated with streptavidine
o ProCell solution (TPA-Tripropylamine) (phosphate buffer)
o CleanCell solution (KOH- cleaning solution)
o Voltage
o Platinum electrode
o Magnet
o Photomultiplier

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Test principles

Test principles

Sandwich principle

o Large molecular weight antigens are measured

Examples: TSH, CA 15-3 II-tests

Competitive principle

o Small molecular weight antigens are measured

Examples: T4, Folate II- tests

Bridging principle

o Large molecular weight antibodies are measured

Examples: Anti-HAV IgM, Anti-HBc IgM

The basic principle

Streptavidin Biotin

Antigen

Antibody

Nucleic acid

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The measuring cell

The measuring cell

The core of the detection unit is the ECL measuring cell, which is designed as a flow-
through cell.
Three operating steps are performed in the cell:
1. Bound/free separation
2. ECL reaction
3. Release of microbeads and cell cleaning
The following figure shows the main components of the measuring cell:

A B C D E

H
I
J
O

N M L K
A Screw B Counter electrode C Optical window
D Distance washer E Top cell F Cell gap
G Gasket H O-ring I Diaphram
J Reference electrode K Outlet fitting L Working electrode
M Movable magnet N Inlet fitting O Cell body

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The measuring cell

Bound/Free separation

o Aspiration of streptavidin microbeads coated with antigen-antibody complex.

o Magnet is activated

Photomultiplier tube

Counterelectrode Counterelectrode

Aspiration of
mixture

Electrode
Magnet

o Antigen-antibody complex is captured by the magnet onto the working electrode

o TPA-ProCell is aspirated to wash the microbeads on the working electrode

Photomultiplier tube

Counterelectrode Counterelectrode

Aspiration of
tripropylamine

Electrode

Magnet

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The measuring cell

o TPA-ProCell flush out the rest of reagent and sample materials

Photomultiplier tube

Counterelectrode Counterelectrode

Tripropylamine

Electrode

Magnet

ECL reaction

o Ruthenium complex and TPA (tripropylamine) are involved in the reactions

o They remain stable as long as no voltage is applied

Ru2+
base state

Platinum electrode

Magnet

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The measuring cell

o Voltage is applied between working and counting electrode and an electrical field
is created
o ECL reaction of ruthenium- tris (bipyridly)2+ and TPA occurs on the surface of
the electrode

Ru2+
excited e-
state TPA•
H+
Ru2+ Ru3+ TPA+•
base state

e- e-
Platinum electrode

Magnet

o TPA is oxidized at the electrode

o Release an electron and forms an TPA radical-cat ion
o Reacts by realizing a proton (H+) to form a TPA radical (TPA*)

Photon
Ru2+
excited e-
state TPA•
H+
3+
Ru2+ Ru
TPA+•
base state

e- e-

Platinum electrode

Magnet

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cobas e 411 analyzer 4 ECL (IA) technology
The measuring cell

o Ruthenium complex also release an electron

o Oxidizing to form the ruthenium cat-ion Ru(bpy)33+ followed by the
chemiluminescent reaction with TPA radical
o Peak of light emission occurs for a short time interval

Photons

Ru2+ TPA
base state

Platinum electrode

Magnet

o ECL reaction is initiated

o A peak of light emission occurs for a short time interval (0.20-0.60 sec)
o Photomultiplier detects and converts the ECL signal into an electric signal
o Corresponding signals is used for calculation of results

ECL intensity (counts) Applied voltage (V)

Time (seconds)

Each measuring cycle needs 42 seconds:

Pre-conditioning ú ~ 2 seconds

Bead capturing/BF separation ú ~ 22 seconds

The magnet is deactivated before the measurement is started, to avoid any

interference.

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4 ECL (IA) technology cobas e 411 analyzer
The measuring cell

Measuring ú ~ 2 seconds

Cleaning ú ~ 14 seconds

Re-conditioning ú ~ 2 seconds

Release of microbeads and cell cleaning

o Cleaning solution is aspirated to the measuring cell

o Microbeads are washed away from the electrode

Photomultiplier tube

Counterelectrode Counterelectrode

Cleaning
solution

Electrode

Magnet

o TPA-ProCell is aspirated
o Surface of the measuring cell is generated
o Measuring cell is ready for an other measurement

Photomultiplier tube

Counterelectrode Counterelectrode

Aspiration of
tripropylamine

Electrode

Magnet

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cobas e 411 analyzer 4 ECL (IA) technology
Advantages of ECL technology

B C

A D

F
G E
A Magnetic microbeads with bound antigen- B Photomultiplier
antibody complex
C Counter electrode D Unbound antibody (ruthenium-labeled)
E Flow channel F Magnet
G Working electrode

Advantages of ECL technology

o Liquid reagents and they are extremely stable (20°C on board up to 12 weeks)
o Combination of enhanced sensitivity and short incubation times leads to high-
quality assays and rapid results
o Large measuring range, minimizes the need for dilutions and repeats, reducing
handling time and reagent consumption
o Applicability of the technique to detect all analytes provides a solid platform for
menu expansion

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User Training Guide · Version 1.0 B-11
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Advantages of ECL technology

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cobas e 411 analyzer 5 Assay overview

Assay overview
Thyroid Cardiac Hormones Diabetes Tumor marker
FT3 c CK-MB s Cortisol c C-Peptide s AFP s
FT4 c CK-MB STAT s DHHEAS c Insulin s CA 125 II s
T3 c l Estradiol II c CA 15-3 II s
T4 c Digoxin c FSH s CA 19-9 s
TSH s Digitoxin c HCG+beta s CA 72-4 s
T-uptake c Myoglobin s HCG+beta STAT CEA s
TG s MYOGLOBIN l s Cyfra 21-1 s
Anti-TG c STAT l s LH s NSE s
Anti-TPO c proBNP s Progesterone II c Free PSA s
Troponin T s Prolactin s Total PSA s
Troponin T SHBC s S100 s
STAT l s Testosterone c
Anemia Bone Varia Hepatitis Retro-viruses
B12 c ß-Cross Laps s IgE s Anti-HAV c HIV antigen s
Ferritin s N-MID Anti-HAV IgM B HIV antigen-Conf.
(package inserts)
Folate II c Osteocalcin s Anti-HBc c HIV combi s
RBD Folate Total P 1NP s Anti-HBc IgM B
(package inserts)
PTH s Anti-HBe c
HBeAg s
Anti-HBs s
HBsAg s
HBsAg-Conf.
(package inserts)

Test principles Obtainability of Pre-treatment STAT assays Pre-dilution

reagent pack size assays assays
18-minute 100 and 200 27-minute l 9-minute
C competition
S sandwich
B bridging

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5 Assay overview cobas e 411 analyzer
Sandwich principle

Sandwich principle

o Large molecular weight antigens are measured

Examples: TSH, CA 15-3 II - tests
o Directly proportional measurement
Means:
Low signal = low concentration
High signal = high concentration

SANDWICH PRINCIPLE

FIRST REACTION

Serum constituents

SECOND REACTION

LIGHT REACTION
Signal (light)

TPA ECL

Magnetic force and Concentration

electrical potential

Ruthenium-labeled
Antigen
antibody TPA Tripropylamine
Biotinylated Streptavidin-coated
antibody microbead

The sandwich principle is applied to higher molecular weight analytes, such as

thyroid-stimulating hormone (TSH).
In the first step, patient sample is combined with a reagent containing biotinylated
TSH antibody and a ruthenium-labeled TSH-specific antibody in an assay cup.
During a nine-minute incubation step, antibodies capture the TSH present in the
sample.

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Sandwich principle

In the second step, streptavidin-coated paramagnetic microbeads are added.

During second nine-minute incubation, the biotinylated antibody attaches to the
streptavidin-coated surface of the microbeads.
After the second incubation, the reaction mixture containing the immune complexes
is transported into the measuring cell.
The immune complexes are magnetically entrapped on the working electrode, but
unbound reagent and sample are washed away by ProCell.
In the ECL reaction, the conjugate is a ruthenium-based derivative and the
chemiluminescent reaction is electrically stimulated to produce light.
The amount of light produced is directly proportional to the amount of TSH in the
sample.
Evaluation and calculation of concentration of the antigen or analyte are carried out
by means of a calibration curve that was established using standards of known antigen
concentration.

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Competitive principle

Competitive principle

o Small molecular weight antigens are measured

Examples: T4, Folate II - tests
o Indirectly proportional measurement
Means:
High signal = low concentration
Low signal = high concentration

COMPETITIVE PRINCIPLE

FIRST REACTION

SECOND REACTION

LIGHT REACTION
Signal (light)

TPA ECL

Magnetic force and Concentration

electrical potential

Ruthenium-labeled
Antigen
antibody TPA Tripropylamine
Biotinylated Streptavidin-coated
antigen microbead

This principle is applied to analytes of low molecular weight, such as T3.

In the first step, sample and a specific anti-T3 antibody labeled with a ruthenium
complex are combined in an assay cup.
After the first incubation, biotinylated T3 and streptavidin-coated paramagnetic
microbeads are added.

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Competitive principle

The still free binding sites of the labeled antibody become occupied, with formation
of an antibody-hapten complex.
The entire complex is bound to the microbeads via interaction of biotin and
streptavidin.
After the second incubation, the reaction mixture containing the immune complexes
is transported into the measuring cell.
The immune complexes are magnetically entrapped on the working electrode, but
unbound reagent and sample are washed away by ProCell.
In the ECL reaction, the conjugate is a ruthenium-based derivative and the
chemiluminescent reaction is electrically stimulated to produce light.
The amount of light produced is indirectly proportional to the amount of antigen in
the patient sample.
Evaluation and calculation of concentration of the antigen are carried out by means
of a calibration curve that was established using standards of known antigen
concentration.

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5 Assay overview cobas e 411 analyzer
Bridging principle

Bridging principle

o Large molecular weight antibodies are measured

Examples: Anti-HAV IgM, Anti-HBc IgM
o Directly proportional measurement
Means:
Low signal = low concentration
High signal = high concentration

BRIDGING PRINCIPLE

FIRST REACTION

Serum
constituents

SECOND REACTION

LIGHT REACTION
Signal (light)

TPA ECL

Concentration
Magnetic force and
electrical potential

Biotinylated
antigen
Serum TPA Tripropylamine
Ruthenium- antibodies Streptavidin-coated
labeled antigen microbeads

The bridging principle is similar to the sandwich principle, except that the assay is
designed to detect antibodies, not antigens, (for example, IgG, Irma, and IgA).
This is accomplished by including biotinylated and ruthenium-labeled antigens in the
reagents for which the targeted antibody has affinity.
In the first step, serum antibodies bind with the biotinylated and ruthenium-labeled
antigens to form an immune complex.
The immune complex then reacts with via the biotinylated antigen.

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Bridging principle

After the second incubation, the reaction mixture containing the immune complexes
is transported into the measuring cell; The immune complexes are magnetically
entrapped on the working electrode, but unbound reagent and sample are washed
away by ProCell.
In the ECL reaction, the conjugate is a ruthenium-based derivative and the
chemiluminescent reaction is electrically stimulated to produce light.
The amount of light produced is directly proportional to the amount of analyte in the
sample.
Evaluation and calculation of the concentration of the antibody are carried out by
means of a calibration curve that was established using standards of known antibody
concentrations.

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Bridging principle

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cobas e 411 analyzer 6 Laboratory exercises
Exercise 3: ECL technology, test overview, and principles

Laboratory exercises

Exercise 3: ECL technology, test overview, and principles

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Knows the basic and principles of the immunoassay technology

Exercises

Which test principle is explained below?

Bridging
principle

Sandwich
principle

Competitive
principle

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User Training Guide · Version 1.0 B-21
cobas e 411 analyzer 6 Laboratory exercises
Exercise 3: ECL technology, test overview, and principles

Match the following:

A ProCell ECL

B Measuring cell B12

C KOH- cleaning solution 42 second cycle

D Large molecular weight antibodies Competitive principle

E Pre-treatment test TPA

F Indirectly proportional measurement Anti-HBc IgM

G STAT test CleanCell

H Electrically chemiluminescent reaction beta-hCG

Quiz

Mark each of the following statements with a l if true:

9-minute tests: two incubation periods, each of 4.5 minutes

18-minute tests: three incubation periods, each of 4.5 minutes

27-minute tests: three incubation periods, each of 9 minutes duration

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User Training Guide · Version 1.0 B-22
 Concepts C

7 Reagent concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3

8 Calibration concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-19
9 Quality control concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-35
10 Laboratory exercises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-41
cobas e 411 analyzer 7 Reagent concept
Reagent kit box labels

Reagent concept

Reagent kit box labels

On each reagent kit box, a large label shows the intended use, storage temperature,
contents, and catalog number of the kit.
A smaller side box label shows the lot and expiration date of the kit and a barcode
number. Both of these labels are shown in the following figure:

A Kit catalog number B Kit lot number

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Reagent packs

Reagent packs

The following figure shows an example of a reagent pack (e-pack):

o Ready-to use reagent packs

o Total reagent compatibility between Elecsys 1010, 2010, E170 module, and the
cobas e 411 analyzer
o Reagent packs have a special 2D (two-dimensional) barcode
o Automatic registration and management of reagent control and calibration
information
o e-pack consists of three bottles:
O Transparent bottle containing microbeads (M) (with a transparent lid)
O Black bottle containing reagent 1 (R1) (with a gray lid)
O Black bottle containing reagent 2 (R2) (with a black lid)

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cobas e 411 analyzer 7 Reagent concept
Reagent barcode label

Reagent barcode label

The reagent barcode label contains information required to run the test on the
system.
This information includes:

A
B

D
E
F
G
H
I

A Test code B Kit catalog number

C Reagent volume within the package D Reagent pack number
E Storage temperature F Abbreviation for in vitro diagnostics
G Reagent pack lot number H Expiration date
I Reagent barcode number (manual input
possible)

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7 Reagent concept cobas e 411 analyzer
Package inserts

Package inserts

T4
Thyroxine
Elecsys 1010/2010 and MODULAR ANALYTICS E170
12017709 122 200 tests

The package insert provides detailed information required to perform the assay. This
information includes:
o Intended use
o Test principle
o Reagent handling and stability
o Calibration and QC information
o Measuring range
o Dilution
o Expected values

Data transfer media

The following data sources are available for cobas e 411 applications:
1. Barcodes on reagent packs (2D matrix barcode)
o Reagent pack
o Diluent reagent pack
o Pre-treatment reagent pack
o BlankCell
2. Barcodes on calibrator and controls vials (1D barcode)
o Calibrator primary vial
o Control primary vial
3. cobas Link (under development) and system database (created during
installation)
o Assay (reagent pack -, e-pack)
o Calibrator and barcode card
o Control and barcode card

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cobas e 411 analyzer 7 Reagent concept
Data concept

Data concept

The information below details the most important data encoded on the barcodes of
various reagent containers and reagent-related data transferred via system data files
(download from cobas link - under development)

1. Barcodes on reagent packs Reagent pack:

(2D matrix barcode)
o Test number (for example, 020)
o Reagent pack lot number
o Reagent pack number
o Test Lot ID (only for tests where calibrators are within
the reagent pack kit)
o Calibrator lot numbers (place for 5 different calibrator
lot target values)
o Rodbard calibration parameters
o Calibration validation criteria
o Control lot numbers (place for 10 different lot numbers
- target values)
o Expiration date

Diluent reagent pack:

o Test number (for example, 020)

o Diluent lot number
o Diluent reagent pack number

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Data concept

2. Barcodes on calibrator and Calibrator primary vial:

control vials (1D barcode)
o Two digits of test number (for example, 020)
o Calibrator lot number
o Test Lot ID (only for tests where calibrators are within
the reagent pack kit)
o Calibrator identification
o Calibrator level number
o Calibrator vial number

Control primary vial:

o Control number
o Control lot number
o Test Lot ID (only for tests where calibrators are within
the reagent pack kit)
o Control identification
o Control level number
o Control vial number

3. System database and cobas Calibrator barcode card:

Link (under development)
o Test number (for example, 020)
o Calibrator lot number
o Test Lot ID
o Calibrator levels
o Place for 10 different reagent pack lots and calibrator
target values
o Expiration date

Control barcode card:

o Control number
o Control lot number
o Test Lot ID
o Place for 28 different tests: test number, target values
and ranges in %
o Expiration date

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Data concept

Reagent Pack Diluent Calibrator Calibrator vial Control Control vial

barcode barcode barcode card barcode barcode card barcode
Test number Test number Test number Test number Place for 28
different tests (test
number, target
values, and ranges
in %
Reagent pack lot Diluent pack lot Place for 10
number number different reagent
pack lots and
calibrator target
values
Reagent pack Diluent reagent Calibrator vial Control vial
number pack number number number
Calibrator levels Calibrator level Control level
number number
Test lot ID Test lot ID Test lot ID Test lot ID Test lot ID
(only for tests
where calibrators
are within the
reagent pack kit)
Calibrator lot Calibrator lot Calibrator lot
numbers (place for number number
five different
calibrator lot target
values)
Control number Control number
Calibrator Control
identification identification
Rodbard
calibration
parameters
Calibration
validation criteria
Control lot Control lot Control lot
numbers (place for number number
10 different lot
numbers - target
values)
Expiration Expiration date Expiration date
date

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Reagents for cobas e 411 tests

Reagents for cobas e 411 tests

The available tests are classified into different groups:

o Thyroid
o Fertility
o Cardiac
o Oncology
o Infectious disease
o Anemia
o Diabetes
o Bone
o Torch
o Other

Diluents for the cobas e 411 analyzer

For most tests where dilution may be necessary, use one of the following diluents:
o Universal Diluent
o MultiAssay
However, some tests—including Anti-HAV, Estradiol, Progesterone, and NSE
(neuron-specific enolase)—require specific diluents.

Diluents Package content Catalog number

Universal 2 bottles, 16 (18) mL each 11732277-122
Universal 2 bottles, 36 (40) mL each 03183971-122
MultiAssay 2 bottles, 16 (18) mL each 03609987-190
NSE 4 bottles, 3 mL each 03004864-122
Hepatitis 2 bottles, 15 mL each 11361252-122

For information on required diluents and recommended dilution factors, refer to the
package inserts of the particular assay reagents.

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System reagents for the cobas e 411 analyzer

System reagents for the cobas e 411 analyzer

The cobas e 411 analyzer uses the following system reagents:

System reagent Package Volume per bottle Stability Stability on Contents

cat. no. content unopened 2-8°C cobas e 411
ProCell 6 bottles 380 mL each 4 weeks 3 days o Conditioning of the electrodes
11662988 Approx. 2 mL per o Transport of the assay reaction
cycle PC/CC mixture
consumption o Washing of the streptavidin-coated
microbeads
o Signal generation
o Phosphate buffer
CleanCell 6 bottles 380 mL each 4 weeks 3 days o Cleaning of the tubing system and of
11662970 Approx. 2 mL per the measuring cell after every
cycle PC/CC measurement
consumption o Conditioning of the electrodes
o KOH detergent
SysWash 1 bottle 500 mL After opening: 2 weeks o Increasing rinsing efficiency between
11930346 3 months pipetting steps.
o Avoiding reagent carryover
o Preventing bacterial growth
o SysWash is added to the distilled
water container (1 + 100)
o Detergent
SysClean 5 bottles 100 mL — Not on o Sodium hypochlorite solution used
11298500 board for cleaning of the measuring cells
(every two weeks)
o Store solution protected from light

System accessories for the cobas e 411 analyzer

System Accessories Description Package content Cat. no. (cobas e 411)

AssayTips Disposable tips for pipetting samples and reagent 30 x 120 tips 11706799-001
cobas e 411
AssayCups Reaction tubes for performing immunoassays 60 x 60 cups 11706802-001
cobas e 411
Clean-Liner Resealable plastic waste bags for the container 1 * 14 bags 11800507-001
CalSet vials Empty snap-cap vials for reconstituted calibrator for direct use 2 x 56 bottles 11776576-322
on the system
Control vials Empty snap-cap vials for reconstituted controls for direct use on 2 x 56 bottles 03142949-122
the systems
SysClean Adapter — 1 piece 11933159-001

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Universal Diluent or MultiAssay (MA) recommendations

Universal Diluent or MultiAssay (MA) recommendations

Reagent type Test Recommended Required

dilution factor concentration of
diluted sample
Thyroid function FT3 Ø
Test FT4 Ø
T3 Ø
T4 Ø
TSH 1:10 with Diluent > 10 µIU/m
MA
T-uptake Ø
TG 1:5 > 50 ng/mL
Anti-TG @
Anti-TPO 1:5 > 200 IU/mL
Cardiac CK-MB 1:2 > 50 ng/mL
Digoxin 1:2 > 2.5 ng/mL
>3.2 nmol/L
Digitoxin 1:2 > 30 ng/mL
> 39 nmol/L
Myoglobin 1:10 > 50 ng/mL
proBNP 1:2 > 15000 pg/mL
> 1770 pmol/L
Troponin T 1:10 > 1 ng/mL
Hormones ACTH Ø
Cortisol 1:10 > 50 nmol/L
* (for urine > 1.8 µg/dl
samples)
DHEAS 1:5 with low > 1.5 µmol/L
concentrated > 45 µg/dl
human sera*
Estradiol II 1:5 with diluent > 1835 pmol/L
MA > 500 pg/mL
FSH Ø
HCG STAT 1:100 > 100 mIU/mL
HCG+β 1:100 > 100 mIU/mL
LH Ø
Progesterone II low concentrated > 6 nmol/L
human sera* > 2 ng/mL

Legend:
# = Diluent Universal can be used to dilute the samples
♣ = Auto dilution not possible due to this assays are three step methods - no information
∞ = Use Diluent Universal for automatic sample predilution
∇ = Auto dilution not possible

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Universal Diluent or MultiAssay (MA) recommendations

Reagent type Test Recommended Required

dilution factor concentration of
diluted sample
Prolactin 1:10 > 50 µIU/mL,
> 2.4 ng/mL
SHBG 1:10 with Diluent > 20 nmol/L
MA
Testosterone Ø (1:5)
Diabetes C-Peptide 1:10 with diluent > 4 ng/mL
(serum and urine) MA > 1.3 nmol/L
Insulin Ø
Tumor marker AFP 1:50 > 20 U/mL,
> 24 ng/mL
CA 125 II 1:5 > 1000 U/mL
CA 15-3 II ∞ 1:10 ♣ > 30 U/mL
CA 19-9 1:10 > 50 U/mL
CA 72-4 1:2 > 150 U/mL
CEA 1:50 > 20 ng/mL
Cyfra 21-1 1:2 > 250 ng/mL
NSE 1:2 with diluent > 50 ng/mL
NSE ∇
Free PSA Ø
Total PSA 1:50 > 2 ng/mL
S100 1:5 with S100 > 1 µg/L
negative human
serum or CalSet
1
Anemia B12 1:2 ♣ > 1000 pg/mL,
>738 pmol/L
Ferritin 1:50 > 40 ng/mL
Folate II 1:2 ♣ > 10 ng/mL,
> 22.7 nmol/L
RBC Folate 1:2 with 0.2% >16.2 nmol/L
ascorbic acid > 8 ng/mL
solution
Bone β-CrossLaps Ø
Osteocalcin 1:5 > 60 IU/mL,
> 144 ng/mL
PTH Ø
Total P1NP 1:2 > 100 µg/L

Legend:
# = Diluent Universal can be used to dilute the samples
♣ = Auto dilution not possible due to this assays are three step methods - no information
∞ = Use Diluent Universal for automatic sample predilution
∇ = Auto dilution not possible

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Checklist of reagent handling

Reagent type Test Recommended Required

dilution factor concentration of
diluted sample
Varia IgE 1:20 > 60 IU/mL,
> 144 ng/mL
Infectious Diseases Anti-HAV with diluent > 20 IU/L
Hepatitis A ∇
Anti-HAV IgM ∞ #
Anti-HBc #
Anti-HBc IgM ∞ #
Anti-HBe #
HBeAg #
Anti-HBs 1:100 > 10 IU/mL
HBsAg #
HIV Ag —

Legend:
# = Diluent Universal can be used to dilute the samples
♣ = Auto dilution not possible due to this assays are three step methods - no information
∞ = Use Diluent Universal for automatic sample predilution
∇ = Auto dilution not possible

Checklist of reagent handling

Reagent Handling

o Did you adjust temperature of the reagent kit before starting the instrument?
o Were the reagent packs within the allowed stability after opening or were the
expiry dates exceeded?
o Was the reagent stored alternately in the fridge and on the analyzer;
(up to 20 hours opened in total on Elecsys 1010)?
o Did you observe any foam?
o Did you store the reagent kit in an upright position and at the right temperature
(2-8°C*)?
* The temperature of the fridge should be 2°C because the beads must not be frozen.
If the kit has been stored <2°C and has not been brought to the correct temperature
before use, recovery problems could occur.

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Checklist of reagent handling

Calibrator Handling

o Did you bring the calibrators to room temperature before starting the instrument?
o Were the lyophilized calibrators carefully dissolved? Did you bring the
reconstituted calibrators to room temperature and allow standing closed for 15
minutes after 1 mL distilled water was added?
o Did you carefully mix the calibrators avoiding the formation of foam?
o Did you transfer the calibrators into the correct bar-coded vial?
o Did you have the calibrator on the analyzer for more than three or five hours in
total (depending on the assay)? Due to possible evaporation effects, not more than
five calibration procedures should be carried out.
o Did you check that the calibrators were within the allowed stability after opening?
o Did you avoid that there were drops hanging on the CalSet cap?
o Did you observe crystallized material on CalSet cap? Discard CalSet vial!
o Did you aliquot and freeze the calibrators? This is recommended for some CalSets,
such as CK-MB, Troponin T, Prolactin, and Progesterone.

Control Handling

o Did you carefully reconstitute the lyophilized controls (see calibrators?) with 3 mL
for PreciControl Universal and PreciControl Tumor Marker (stand closed for 30
minutes), and 2 mL for PreciControl Cardiac (stand closed for 15 minutes)?
o Did you transfer the controls into the correct bar-coded vial?
o Did you check that the controls were within the allowed stability after opening
and that the expiry date was not exceeded?
o Did you observe foam on the controls?
o Did you avoid that there were drops hanging on the CalSet cap? Did you check if
there were drops hanging on the control vial cap? Clean lid of controls cap
carefully with a paper tissue.
o Did you observe crystallized material on control vial cap? (if so, discard control
vial)
o Did you aliquot and freeze controls? This is recommended for PreciControl
Universal, Cardiac and Tumor Marker. Did you adjust temperature?

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Checklist of reagent handling

Sample Handling

o Did you use the recommended sample containers (outside diameter < 13 mm)?
o Did you notice air bubbles or foam on the surface of the sample?
o Did you check that the sample stability was not exceeded? Check the package
insert.
o Was the minimum sample volume within the specified range?
o Did you prepare the sample material carefully? Did you allow 30 minutes waiting
time for clotting? Did you centrifuge the samples before putting them on the
analyzer?
o Did the sample contain precipitates? Sample containing precipitates must be
centrifuged before testing at a minimum of * 2500 rpm for 10 minutes (primary
and normal cups).
o Did you check if there was enough sample volume (plasma)?
o Did sample cups fit correctly in sample disk or rack?

System Reagent Handling

o Did you store the system reagents at room temperature?

o Did you allow the system reagents to reach the correct temperature on board (15
minutes from room temperature/1 hour from 4°C) before starting the
instrument?
o Did you check that the system reagents were within the allowed stability after
opening and that the expiry date was not exceeded?
o Did you close the system reagent bottles overnight?
o Did you mix the contents of different bottles?
o Did you replace the empty bottles from left to right side on the cobas e 411
analyzer?
o Did you observe any foam within system reagents?

System Water Handling

o Did you use distilled water according to specification (conductivity 10 S)?

o Did you carefully refill containers with distilled water in order to avoid air
bubbles?

Diluent

o Did you use the recommended dilution ratio?

o Is the end concentration after dilution still according to recommendations?
o Did you check that the Diluent was within the allowed stability after opening and
that the expiry date was not exceeded?
o Did you check the Diluent is recommended for this particular assay?
o Please check the attached “dilution list”.

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cobas e 411 analyzer 7 Reagent concept
Checklist of reagent handling

Maintenance

o Did you regularly perform maintenance as described in the Operation Manual?

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Checklist of reagent handling

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cobas e 411 analyzer 8 Calibration concept
General information about calibrators

Calibration concept

General information about calibrators

For most tests, calibrators can be ordered separately. Each kit contains barcoded
calibrator vials.
Some calibrators are in a ready to use liquid form and require no further action.
A few of the calibrators are lyophilized in glass bottles and must be reconstituted
before being transferred into plastic barcode-labeled vials. Reconstituted calibrators
can store in the plastic vials after transfer.
Calibrators also have color-coded caps to assist you in identification.
The information which calibration can be used for which test is given in the package
insert of the reagent.

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8 Calibration concept cobas e 411 analyzer
Calibration kit

Calibration kit

D
B

A Empty calibrator vials to be filled for CalSet 1 B Bottles containing calibrators to be

and 2 reconstituted according to the package
inserts
C Calibrator barcode cards D Package inserts
E Extra labels for calibrator aliquots that
should be kept separately (six labels for each
control level)

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cobas e 411 analyzer 8 Calibration concept
Overview of calibrators

Overview of calibrators

Test Calibrator Calibrator Calibrator Freezing possible Calibrator volume

Cat.no. stability opened stability on lyophilized/ready to use? per bottle/
Calibrator 2-8°C board 20-25°C Pipetting volume

FT3 8 weeks 5 hours Y — 1 mL

3051994 15 µl
FT4 12 weeks 5 hours Y — 1 mL
11731661 15 µl
T3 8 weeks 5 hours Y — 1 mL
11731548 30µl
T4 12 weeks 5 hours Y — 1 mL
12017717 15 µl
TSH 12 weeks 5 hours Y — 1.3 mL
11731483 50 µl
T-uptake 12 weeks 5 hours Y — 1 mL
11731505 15 µl
TG 3 days 5 hours Y 1 x (-20 C/3 month) 1 mL
11820940 20 µl
Anti-TG 6 weeks 5 hours Y Not possible 1.3 mL
10 µl
Anti-TPO 6 weeks 5 hours Y Not possible 1.5 mL
20 µl
CK-MB 2 weeks 5 hours Y 1 x (-20 C/3 month) 1 mL
11731572 (9 15 µl
min)/11821601
(18 min)
Myoglobin 12 weeks 5 hours Y 1 mL
11820893 (9 15 µl
min)/12178222
(18 min)
proBNP 2 weeks 5 hours Y 1 x (-20 C/3 month) 1 mL
03121658 20 µl
Troponin T 2 weeks 5 hours Y 1 x (-20 C/3 month) 1 mL
04660307 (9 15 µl
min)/12017652
(18 min)
Digoxin 12 weeks 5 hours Y — 1.5 mL
11820907 10 µl
Digitoxin 12 weeks 5 hours Y — 1 mL
03002667 15 µl
HCG STAT 12 weeks 5 hours Y — 1 mL
10 µl
HCG+β 12 weeks 5 hours Y — 1 mL
10 µl

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8 Calibration concept cobas e 411 analyzer
Overview of calibrators

Test Calibrator Calibrator Calibrator Freezing possible Calibrator volume

Cat.no. stability opened stability on lyophilized/ready to use? per bottle/
Calibrator 2-8°C board 20-25°C Pipetting volume

ACTH — Use Y 1 x (-20 C/3 month) 1 mL

03255760 immediately 50 µl
and only once
Cortisol — Use only once Y 1 x (-20 C/3 month) 1 mL
20 µl
DHEAS — Use only once Y 1 x (-20 C/3 month) 1 mL
03000095 15 µl
Estradiol II — Use only once Y 1 x (-20 C/3 month) 1 mL
03064921 35 µl
FSH II — Use only once Y 1 x (-20 C/3 month) 1 mL
03032680 0 µl
LH II — Use only once Y 1 x (-20 C/3 month) 1 mL
03561097 20 µl
Progesterone II Use only once Y — 1 mL
12145391 30 µl
Prolactin II — Use only once Y 1 x (-20 C/3 month) 1 mL
03277356 10 µl
SHBG — Use only once Y 1 x (-20 C/3 month) 1 mL
03052028 10 µl
Testosterone II — Use only once Y 1 x (-20 C/3 month) 1 mL
03005658 50 µl
C-Peptide — Use only once Y 1x 1 mL
03184919 (-20 C/3 month) 20 µl
Insulin — Use only once Y 1x 1 mL
12017504 (-20 C/3 month) 20 µl
AFP II 6 weeks 5 hours Y 1x 1 mL
04487761 (-20 C/6 weeks) 10 µl
CA 125 II 12 weeks 5 hours Y — 1 mL
11776240 40 µl
CA 15-3 II 12 weeks 5 hours Y — 1 mL
03045846 20 µl
CA 19-9 4 weeks 5 hours Y 1x 1 mL
11776215 (-20 C/2 month) 10 µl
CA 72-4 6 weeks 5 hours Y — 1 mL
11776274 30 µl
CEA 12 weeks 5 hours Y — 1 mL
11731645 10 µl
Cyfra 8 weeks 5 hours Y — 1 mL
21-1 20 µl
11820974
NSE 6 weeks 3 hours Y — 1 mL
12133121 20 µl

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cobas e 411 analyzer 8 Calibration concept
Overview of calibrators

Test Calibrator Calibrator Calibrator Freezing possible Calibrator volume

Cat.no. stability opened stability on lyophilized/ready to use? per bottle/
Calibrator 2-8°C board 20-25°C Pipetting volume

free PSA 12 weeks 5 hours Y — 1 mL

03289796 20 µl
total PSA II 6 weeks 5 hours Y — 1 mL
04485220 20 µl
S100 4 weeks 5 hours Y 3 month (freeze only 1 mL
03289834 once) 20 µl
Vitamin B12 II 3 days Use only once Y 3 months (freeze 1 mL
04572459 only once) 15 µl
Ferritin 12 weeks 5 hours Y — 1 mL
03737586 10 µl
Folate II# 3 days Use only once Y 3 months (freeze 1 mL
04476441 only once) 30 µl
IgE 12 weeks 5 hours Y — 1 mL
11930427 10 µl
β CrossLaps/ 12 weeks 5 hours Y — 1 mL
serum 50 µl
11972316
N-MID 1 week 5 hours Y 1x 1 mL
Osteocalcin (-20°C/3 month 20 µl
11972111
PTH 2 weeks 5 hours Y 1x 1 mL
11972219 (-20°C/3 month 50 µl
Total P1NP 1 week up to 24 hours Y 5x 1 mL
03141080 (-20°C/3 month 20 µl

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8 Calibration concept cobas e 411 analyzer
Overview of calibrators

For all Infectious disease assays:

o Calibrators are part of the test kit
o Lot number of reagent pack and calibrators are identical
Test Calibrator Calibrator Calibrator Freezing possible Calibrator volume per
Cat.no. stability opened stability on lyophilized ready to use? bottle/
Calibrator 2-8 C board Pipetting volume
20-25 C
Anti-HAV 8 weeks 5 hours Y — 1 mL
50 µl
8 weeks 5 hours Y — 0.67 mL
10 µl
8 weeks 5 hours Y — 1 mL
40 µl
8 weeks 5 hours Y — 1 mL
10 µl
8 weeks 5 hours Y — 1 mL
35µl
8 weeks 5 hours Y — 1 mL
35 µl
8 weeks 5 hours Y — 1.3 mL
40 µl
12 weeks 5 hours Y — 1.3 mL
50µl
4 weeks 5 hours Y — 1 mL
50 µl
8 weeks 5 hours Y — 1 mL
30 µl

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cobas e 411 analyzer 8 Calibration concept
Overview of calibrators

1. Reference standard curve (Roche Development)

Calibration is required to determine the concentration of an unknown substance as

accurately as possible.
o World Health Organization “WHO”
o Curve uses 10-12 points
o Independent of reagent lot, reagents, and analyzer conditions
o Basic for the production of the master calibrators

RD Development

Accuracy
Effort
RD Production

Customer

2. Master calibration curve (Roche Production)

o Curve uses 5 or 6 points (master calibrators)

o Uses lot-specific test reagent
o Master curve shape characterized by four-parameter Rodbard function
o Data encoded in lot-specific reagent barcode label (2D)
o Target values encoded into CalSet cards
Reagent pack barcode label Calibrator card

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Data transfer rules

3. Update of master calibration curve (at customer site)

This calibration is necessary to adjust the Rodbard parameters to the routine

conditions.
o By measuring two calibrators (CalSet 1 and CalSet 2)
o Measurement calibrators mathematically combined with encoded data on the
Calibrator Barcode Card or reagent barcode label (2D)
o cobas e 411 analyzer calculates Lot Calibration or Regent Pack Calibration
o Sample measurements calculated from this concentration

Master Calibration Data Calibration

with two calibrators

Data transfer rules

Calibrator data source

Calibrator data are encoded on the 2D barcode of the reagent pack

o If the reagent pack was produced after the CalSet (calibrator set), the target values
from the reagent pack have priority and are used for generating the calibration
curve.
o If the reagent pack was produced before the CalSet, data followed by target values
from the calibrator card are used for generating the calibration curve.

Control target values from Control target values are provided by different data sources.
different data sources
The following priority rules regulate which control target value is used:

o Priority 1: Manually entered control target values

o Priority 2: Reagent pack 2D barcode
o Priority 3: Control barcode card or data downloaded from cobas Link (under
development)

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Lot calibration and reagent pack calibration

Lot calibration and reagent pack calibration

Lot calibration

A lot calibration is a calibration performed:

o With a fresh reagent pack
o That has not been on board the analyzer longer than 24 hours and all calibration
validation criteria are acceptable
o Lot calibration is valid for all other reagent packs of the same lot
o Reagent-specific calibrators are used to update two of the four Rodbard curve-
defining parameters. This adjusts the curve to match the original lot specific
calibration curve

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8 Calibration concept cobas e 411 analyzer
General calibration rules

Reagent pack calibration

A reagent pack calibration will be performed with a reagent:

o That has been on board the analyzer more than 24 hours
o Or is generated by an operator-released calibration
o Reagent pack calibration is valid for one specific reagent pack only.
o Reagent pack which is expired, gets a reagent packs only, even though all
calibration criteria are fulfilled and reagent pack is on board in between 24 hours

Reagent pack

On analyzer < 24 hours On analyzer > 24 hours

All calibration criteria All calibration criteria

acceptable acceptable
Automatic system release Automatic system release

Reagent pack calibration

Lot calibration
(system-released)

Valid for all reagent packs of the

Valid for this reagent pack only
same lot

Controls and samples before Controls and samples after

Controls and
operator release will use the system release will use this
samples
previous lot calibration reagent pack calibration

General calibration rules

o Calibration can be carried out at any time

o Test-specific calibrations are used
o Calibrations are carried out in duplicate
o 2-point calibration for each new reagent lot
o Expired CalSets must not be used

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Calibration stability

Calibration stability

Recommendation:
o As required: for example, quality control result outside the specified range
o 2-point calibration every month/28 days (when using the same reagent lot)
o 2-point calibration every seven days (when using the same reagent pack on the
analyzer)
o More frequently if required, such as for pertinent regulations (qualitative assays
or, for example, Anti-TPO)

Reagent stability

o Unopened at 2-8°C up to the stated expiry date

o After opening six to twelve weeks at 2-8°C (depending on the assay)
o After opening two to eight weeks on board (depending on the assay)

Overview of calibrators and stability

Liquid calibrators:

o Unopened at 2-8°C up to the stated expiry date

o After opening six to twelve weeks at 2-8°C (depending on the assay)
o After opening two to eight weeks on board (depending on the assay)

Lyophilized calibrators:

o Unopened at 2-8°C up to the stated expiry date

o Reconstituted calibrators 2 to 12 weeks at 2-8°C (depending on the calibrator/test)
o Reconstituted calibrator 3 month at -20°C (only freeze once)
o Reconstituted calibrator up to (three*) five hours in total on board (20-25°C)
o * Three hours, for example, for CalSet Prolactin, CalSet Progesterone
* check package inserts for details!

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Calibration quality criteria

Calibration quality criteria

The quality criteria of a calibration are displayed in the Working Information

window.

Quantitative tests
o Min (minimum signal)
o Missing values
o Monotony of curve (slope)
o DIFF. (minimum acceptable difference)
o DUPL. (deviation of duplication)
o Sys Error
o Calibration factor

Qualitative tests
o Min (minimum signal)
o Missing values
o Slope (monotony of curve)
o DIFF. (minimum acceptable difference)
o DUPL. (deviation of duplication)
o Sys Error
o Maximum signal

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cobas e 411 analyzer 8 Calibration concept
Calibration quality criteria

Calibration quality criteria for quantitative and qualitative tests

Min (minimum signal) The measured signal of the calibrator replicate must be above the minimum value.
Values are test dependent and are encoded in the reagent barcode. If one or more
calibrators are below the recommended minimum signal level, the calibration is failed
(red).

Missing values Duplicate determinations of two calibrators are used to adjust the master calibration
curve stored on the reagent pack barcode.
If one of more calibrators is missing, the calibration is failed (red).

Monotony All measured calibrator values must fall in ascending (sandwich or bridging
principle) or descending (competition principle) order. This is termed monotony.
If the monotony is not given, than the calibration is red.

Diff. (Minimum acceptable The minimum acceptable difference is defined as the difference in percent of the
difference) values between calibrator 1 and 2. This difference must amount to at least 30% for the
calibration to be accepted.
The difference between the negative and positive calibrator signal values must be
greater than the allowable value limit. This limit is test dependent and is encoded in
the reagent barcode.
The minimum acceptable difference is listed as OK or NG (Not Good).

Dupl. (Deviation of duplication) The deviation of duplicate measurements is a check of the signal values for each
replicate of a calibrator.
If the difference between the duplicate measurements of one or more calibrator level
is too high (in general > 10%), the calibration is failed (red).
The signal values are used to calculate the mean value of the duplicate measurements.

Sys Error A hardware error occurred during a calibrator measurement.

If either 1 (Cal 1) or 2 (Cal 2) appear in this field, the result is a failed calibration
(red).

Factor A curve position check against the most recent lot calibration produces a calibration
factor. This field displays a number that represents this factor.
Each new lot calibration (L-Cal) utilizes a calibration factor of 1. For all subsequent
reagent pack calibrations (R-Cal), a new calibration factor is calculated.
The calibration factor is the quotient of the slopes of the actual performed calibration
and the related stored calibration.
The calibration factor is only used as calibration validation criteria and not used for
sample calculation.
Successful calibration: range 0.8 - 1.2
Red calibration: range < 0.8 or > 1.2

The calibration factor criterion is only used in validating R-Cals.

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Calibration status display

The following formulae show the relationship between lot calibration and reagent
pack calibration:

t
Calibration factor for each Lot calibration = ---1- = 1
t1

CalSet 1 signal (standardization) – CalSet 2 signal (standardization)

t 1 = ------------------------------------------------------------------------------------------------------------------------------------------------------------------------
actual CalSet 1 l signal – actual CalSet 2 l signal

CalSet 1 signal (standardization) – CalSet 2 signal (standardization)

t r = ------------------------------------------------------------------------------------------------------------------------------------------------------------------------
actual CalSet 1r signal – actual CalSet 2 r signal

t actual CalSet 1r signal – actual CalSet 2 r signal

Calibration factor for Reagent pack calibration = ---1- = --------------------------------------------------------------------------------------------------------------------------
-
tr CalSet 1 l signal – CalSet 2 l signal
Example:

– 22000 counts = 0.88

TSH = 1000
---------------------------------------------------
1100 – 25000 counts

Calibration quality criteria for qualitative tests

The previous mentioned criteria also apply to the qualitative assays and in addition
one calibration Quality Criteria will be 'validated':

MIN/MAX (minimum/ The measured signal of the calibrator should fall between the designated minimum
maximum signal) and maximum signal. Minimum and maximum signals are test dependent and are
encoded in the reagent barcode.
If one or more signals are out of the allowable minimum/maximum signal range, the
calibration is failed (red)

Calibration status display

Status Message
L-Calib. was generated A new reagent pack lot was registered and a calibration
requested. The calibration was successful and has been
stored in the system as an L-Cal.

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Different reason to calibrate a test

Status Message
L-Calib. could not be generated The calibration was not accepted as an L-Cal. The system
Released as R-Calib. by System has released the calibration as an R-Cal.
The reagent pack used for calibration was on the analyzer
for more than 24 hours since its registration.
The calibration is valid only for this reagent pack.
An L-Cal can only be generated with a reagent pack that
has been on the analyzer for less than 24 hours since its
registration.
L-Calib. could not be generated! The attempted calibration is failed.
Calib. with expired reagent pack. This message can be combined with any other previously
described calibration messages with the exception of
“L Calib. was successful”.

Different reason to calibrate a test

Reason for a calibration Status in the Software Consequence

for a Cause
New installation of the system Change over Calibration has to be
or an new assay done
New lot for that specific reagent Change over Calibration has to be
pack/assay done
For example, hardware problem Failed Calibration has to be
done
Lot calibration 28 days is over, Timeout Roche recommendation,
R/P calibration 7 days is over as well as customer
decision
Controls are outside of QC violation Roche recommendation,
confidence limit - user definable as well as customer
range (for example, +/- 2SD decision
range) (automatically)
Repeating of controls due to, for Manual (no automatic Customer decision
example, wrong handling status is displayed on
the screen, has to be
requested manually)

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Different reason to calibrate a test

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cobas e 411 analyzer 9 Quality control concept
General information about controls

Quality control concept

General information about controls

The controls are used to verify the calibration curve and to ensure that the calculated
sample results (based on this calibration) are correct. In the daily routine, they are
used to monitor the accuracy and precision of the tests.
The target values of the controls have to be recovered within a defined range (3 SD or
manual defined reference range, for example, non-Roche controls). This will be
evaluated by the Quality Control Program of the software.
Roche Diagnostics offers ready for use controls and lyophilized ones, which have to be
reconstituted according to the advice in the package inserts. In the package insert you
can find additional 'Handling' information, which is helpful if you want to aliquot the
controls.
Roche Diagnostics offers controls for several parameters in one control, but also for
one parameter only. The information which control can be used for which test is
given in the package insert of the reagent.

Control kit

A
B E

C
D F
G

A Empty calibrator vials to be filled with level 2 B Empty calibrator vials to be filled with level 1
controls controls
C Bottles containing level 2 controls to be D Bottles containing level 1 controls to be
reconstituted according to the package reconstituted according to the package
inserts inserts
E Control barcode cards F Package inserts
G Extra labels for control aliquots that should
be kept separately

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Overview of control types and relevancy to tests

Overview of control types and relevancy to tests

PreciControl Universal PreciControl PreciControl Cardiac PreciControl TNT PreciControl TSH

MultiAnalyte
L L L L R
AFP C-Peptide CK-MB Troponin T TSH
Cortisol Insulin CK MB STAT Troponin T STAT
DHEAS Digoxin
Insulin Myoglobin
SHBG Myoglobin STAT
IgE proBNP
E II
LH
PROG
PRLFSH
Testo
FT3
FT4
T3
T4
TSH
T-uptake
HOG beta STAT
HOG+beta

PreciControl Anemia PreciControl PreciControl Bone PreciControl S100 PreciControl

Tumormarker Anti-TPO
L L L L R
B12 AFP ß-Cross Laps S-100 Anti-TPO
Ferritin CEA N-MID
Folate II CA 125 II Osteocalcin
CA 15-3 II Total P 1NP
CA 19-9 PTH
CA 72-4 s
Cyfra 21-1
Ferritin
HCG+beta
NSE
Free PSA
Total PSA
Anti-TG

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Control stability

PreciControl PreciControl PreciControl PreciControl Anti-HBc PreciControl

Anti-TG Anti-HAV Anti-HAV IgM Anti-HBc IgM
R R R R R
Anti-TG Anti-HAV Anti-HAV IgM Anti-HBc Anti-HBc IgM

PreciControl PreciControl PreciControl PreciControl Anti-HBs PreciControl

Anti-H Be Anti-H BeAG Anti-H Bs AG HIV Ag
R R R R R
Anti-H Be Anti-H BeAG Anti-H Bs Anti-HBs AG HIV Antigen

PreciControl PreciControl PreciControl

HIV combi Toxo IgG Toxo IgM
R R R
HIV combi Toxo IgG Toxo IgM

Volume per bottle Lyophilized Stability opened 2-8°C Stability on board

Minimum: 0.67 mL Ready to use 3 or 5 days 3, 4, 5, 6, 7, 8, 24 hours
Maximum: 3 mL L, R 2, 4, 6, 8, and 12 weeks
* Check package inserts for details

Control stability

Liquid controls:

o Unopened at 2-8°C up to the stated expiry date

o After opening 3 to 5 days or 2 to 12 weeks at 2-8°C (depending on the control/test)
o Up to 3-24 hours in total on board (20-25°C) (depending on the control/test)

Lyophilized controls:

o Unopened at 2-8°C up to the stated expiry date

o Reconstituted QCs 3 to 5 days or 2 to 12 weeks at 2-8°C (depending on the
control/test)
o Up to 3-24 hours in total on board (20-25°C) (depending on the control/tests)
o Reconstituted QCs 1 to 3 months at -20°C - only freeze once for most of the
controls
Check package inserts for details.

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Overview of control types

Overview of control types

PreciControls Package content Cat.no.

Universal 2 levels, each level two bottles 11731416-122
Cardiac 2 levels, each level two bottles 03530477-190
MultiAnalyte 2 levels, each level two bottles 03609979-190
ACTH 2 levels, each level two bottles 04655346-190
TNT 2 levels, each level two bottles 03530469-190
TSH 1 level, four bottles 11776479-122
Tumor marker 2 levels, each level two bottles 11776452-122
S100 2 levels, each level two bottles 03330648-190
Bone 3 levels, each level two bottles 11972227-122
Anemia 3 levels, each level two bottles 04415299-190
Anti-TG 2 levels, each level one bottle Controls are part of the test kit.
Anti-TPO 2 levels, each level one bottle Controls are part of the test kit.
Anti-HAV 2 levels, each level eight bottles 11876350-122
Anti-HAV IgM 2 levels, each level eight bottles 11876368-122
Anti-HBc 2 levels, each level eight bottles 11876325-122
Anti-HBc IgM 2 levels, each level eight bottles 11876333-122
Anti-HBe 2 levels, each level eight bottles 11876384-122
HBeAg 2 levels, each level eight bottles 11876376-122
Anti-HBs 2 levels, each level eight bottles 11876317-122
HBsAg 2 levels, each level eight bottles 11876309-122
HIV Ag 2 levels, each level eight bottles 11971735-122
HIV combi 3 levels, each level five bottles 03599612-190

Priorities of control target value

There are different possible sources for the target values, which are used in the QC of
the software:
Priority 1: Target values of controls are entered manually
Priority 2: Target values of controls on the 2D reagent barcode
Priority 3: Target values of controls on the control barcode card
This means, once a target value of a control is entered manually this value is valid
until the customer uses a new control lot.
If the customer deletes this control in the control definition screen and scans the
control barcode card once again, then the manual input is no longer valid.

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Control settings and consequences

Control settings and consequences

There are two possibilities to perform QC measurements:

Timeout A calibration is recommended by system after a certain time interval (timeout for Lot.
or R/P calibration).
The result of the QC measurement, which follows the timeout calibration, is
displayed in the Run Status screen.
The ± 3 SD range is used in the software for control validation.

QC violation A control measurement is requested manually and if the QC result exceeds the
confidence limit (which can be defined for each test and control level) calibration is
automatically recommended by the system.
The QC results are displayed in the Run status screen.

The decision whether option 1 or option 2 is selected, depends on the workflow of the laboratory.
The Timeout calibration recommendation is test-specific, and is transmitted via the reagent pack
barcode label.
If QC violation is the preferred option, the selection of QC Violation has to be done for each test
individually in Utility-Application screen.

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Control settings and consequences

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cobas e 411 analyzer 10 Laboratory exercises
Exercise 4: Reagent concepts

Laboratory exercises

Exercise 4: Reagent concepts

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Understand the reagent concept basics
o Know about the correct handling of reagents

Exercises

The e-pack consists of three bottles. Which of the three bottles contains the
microbeads?

R1 bottle with a grey lid

R1 R2
M R2 bottle with a black lid

M bottle with a transparent lid

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Exercise 4: Reagent concepts

Match the following:

A Test code number 30 x 120

B Reagent packs Package inserts

C 2D matrix barcode Host

D Reagent barcode number Diluent reagent packs

E Calibrator and QC cards Ready to use

F cobas Link Test parameter download

G Highest priority rule Manually entered control

H Provides detailed information Manual input possible

I AssayTips cobas e 411 Target values

Quiz

Mark each of the following statements with a l if true for system reagents:

CleanCell is stable on board for three days

SysClean avoids reagent carryover and prevents bacterial growth

ProCell is used for washing the streptavidin-coated microbeads

SysWash sodium hypochlorite solution is used for liquid flow cleaning maintenance

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Exercise 5: Calibration concepts

Exercise 5: Calibration concepts

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Knows about the correct handling of calibrators
o Understand the basic calibration rules
o Interpret the calibration results
o Remedy the situation of calibration causes

Exercises

Calibrator barcode cards

Empty calibrator vials to be

filled for CalSet 1 and 2
Package inserts

Extra labels for calibrator

aliquots
C Bottles containing calibrators to
be reconstituted
A

D
B

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Exercise 5: Calibration concepts

The example calibration criteria below applies to which test type?

Qualitative tests

Or
Quantitative tests

Match the following:

A Lot calibration Automatic calibration request

B Calibration criteria Cutoff assay

C Calibration stability Valid for all other reagent packs of the same lot

D Minimum/maximum signal Controls are outside of confidence limit

E Reagent pack calibration Calibration factor

F Change over Expired CalSets

G Failed calibration 28 days

H QC violation More than 24 hours

I Cannot be used Calibration causes

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cobas e 411 analyzer 10 Laboratory exercises
Exercise 5: Calibration concepts

Quiz

Mark each of the following statements with a l if true for the calibration concept:

All of the calibrators are lyophilized in glass bottles and must be reconstituted

TSH calibrators are ready to use and stable on board for five hours

A reagent pack that has expired gets a reagent pack calibration only

Calibration is carried out in single determination

Minimum signal: if one or more calibrators are below the recommended minimum
signal level, the calibration is failed (red)

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Exercise 6: Quality control concepts

Exercise 6: Quality control concepts

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Understand the basics of the quality control concept
o Knows about the correct handling of controls

Exercises

Empty control vials for level 2

Package inserts

Bottles containing controls for

level 2 to be reconstituted
Control barcode cards
A
B E Extra labels for control
aliquots
C Bottles containing controls for
D F level 1 to be reconstituted
G Empty control vials for level 1

Match the following:

A C-Peptide Target value

B Controls hCG-beta test

C PreciControl TSH PreciControl MultiAnalyte

D Lyophilized Ready to use

E Control barcode card Are used to verify calibration curve

F To be recovered within a defined range Priority 3

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Exercise 6: Quality control concepts

Quiz

Mark each of the following statements with a l if true for the quality control concept:

In the daily routine, QCs are used to monitor the accuracy and precision of the tests

If a target value of calibrator is entered manually, this value is valid until a new lot is
installed
The target values of the controls have to be recovered within a defined range

There are two basic possibilities to perform QC measurements: timeout and QC

violation

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Exercise 6: Quality control concepts

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 Software description D

11 System Overview screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

12 Workplace menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-15
13 Reagent menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-25
14 Calibration menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-29
15 Quality Control menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-37
16 Utility menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-53
17 Laboratory exercises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-79
cobas e 411 analyzer 11 System Overview screen
Overview

System Overview screen

Overview

The System Overview screen has a central role within the cobas e 411 analyzer
software. From here, an overview of the whole system is given at any time.
This screen displays:
o Status of each reagent
o Details of the reagents which are loaded
o Details of current inventory levels
o Status of the individual samples, controls and calibration (sample tracking screen)
o Access to other screens by choosing the corresponding button or area of the screen
o Work Flow Guide can use to prepare the system for daily routine operation
o Troubleshoot the system, if data or instrument alarms are displayed
The System Overview screen is divided into the following areas:
o Work Flow Guide area
o Reagent overview and Inventory area
o Global Buttons (Functions, main menu buttons, and global screens)

A B C
A Work Flow Guide area B Reagent overview and Inventory area
C Global Buttons (Functions, main menu
buttons, and global screens)

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Overview

Work Flow Guide area

o Consists of six buttons, whose colors vary depending on their status

o Guides the user through the daily routine
o By choosing the buttons, screens are displayed that enable you to take actions
Buttons Color Status/description
Maintenance Blue System ready (active)
Display the Utility/Maintenance screen, used to perform
maintenance actions
Sample Data Clear Blue System ready (active)
(Yellow)? Open (80% - 90% of the databank capacity is reached.)
Red The database is full. The operator should delete the
results.
Display the 2 option: clear sample data and back up the
data before clearing
Delete sample data: Deletes all records of the samples and
moves QC data to the QC view. If your system is
connected to a host, make sure that all data have been
uploaded before performing the Sample Data Clear is
pressed
Reagent Load List Blue System ready (active)
Yellow At least one parameter falls below the limit for the reagent
level check

Red A reagent for at least one test is unavailable (missing or

empty)
Print a Reagent Load/Unload List, which is a list of
reagents that need to be loaded or unloaded in order to
carry out the daily routine
Calib/QC Load List Blue System ready (active)
Yellow 1. Calibrations change over
2. Calibration failed
3. Timeout
4. A manual request for calibration and QC was done
Print the Calibration and QC Load Lists.
Parameter Download Blue System ready (active)
(Yellow)? Open
(Red)? Open
Choose the button to download parameters over cobas
Link
Sample Tracking Blue System ready (active)
Display the status of the racks and sample tubes currently
in the sample unloader

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Overview

The System Overview screen has a central role within the cobas e 411 analyzer
software. From here, an overview of the whole system is given at any time.

A B C D E
A Direct access to Utility/Maintenance to B Delete all patient results and moved any
perform maintenance issue control results to QC View
C Reagent Load List and Calibration/Control D Download for parameter data, calibrator and
Load List can be printed control data it is transmitted from SmartCOM
(Draft version)
E To check the sample status and to view
sample results

Sample Tracking (disk system)

The Sample Tracking screen provides an overview of the samples in the disk and
allows the operator to search for samples that have already been registered by the
system.

The graphic shows the status of the results for each sample in positions 1 to 30 on the
sample disk. A legend of symbols and colors is displayed in the Position Status area.

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Overview

Sample Tracking (rack system)

The Sample Tracking window provides an overview of the samples that have already
been registered by the system and are currently located in the output buffer or
unloader (C-line).

This graphic shows the status of the racks in the output buffer. The output buffer
contains five racks, each containing five sample positions, giving a total of 25 samples.
The possible status options are:

Empty (E) The selected position is empty

Processing (P) The sample, control or calibrator is in process (all assays have
been pipetted), but results are not yet ready
Incomplete (I) One or more requested measurements could not be
completed, due to, for example, the result is outside
measuring range or test could not be processed
Occupied (O) The sample is requested for tests after a scan process

Completed (C) The processing of the sample has been completed

satisfactorily
Stop BC (S) This sample position contains a stop barcode (only on rack
system)

STAT samples appear yellow throughout operation, even though their actual status
changes.

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Overview

Reagent Overview and Inventory area

This area consists of three sections:

A B C
A Reagent list B Reagent rotor graphic
C Inventory area, comprising: ProCell (PC) and
CleanCell (CC), solid waste level, and Cup
and Tip inventory

Reagent list

Column Description
No. Position of the reagent pack in the reagent rotor
Test Name of the test
Status Current and Standby reagents are displayed, the order of precedence for
reagent pack:
1. The reagent pack with the current lot number
2. The reagent pack that expires first
3. The reagent pack with the oldest registration date (within the same lot
4. The reagent pack with the lowest filling level
5. The reagent pack in the lowest position
Determinations Displays the number of determinations remaining in the reagent pack.

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Overview

Reagent disk graphic

Inner block: reagent pack Active Reagent pack is currently in use for this test.

Warning Remaining tests in this reagent pack are below the yellow alarm
level
Caution There is no more reagent available for this assay on board.

Expired The expiry date of the reagent pack has expired.

Stand-by This is a standby reagent pack.

Zero tests, Used up The reagent pack has been used and is empty. There is still
reagent available in another reagent pack on the analyzer.
Free Pos. There is no reagent pack in this position.

Middle block: Calibrator Valid Calibration has been successfully generated.

Requested Calibration has been requested.

Failed Calibration of the reagent has failed.

Outer block: QC Valid QC result is within the confidence limits.

Requested Requested for QC measurement.

Violated QC result is not within the confidence limits.

N.A. Not applicable. A confidence limits is not yet assigned for this
test, or a QC measurement has not yet been performed.

Inventory area

This area comprises:

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Overview

o ProCell (PC) and CleanCell (CC) levels

o Solid waste level
o Cup and Tip inventory
Column Description
PC1/PC2 in % The blue bar displays the amount of ProCell (PC) remaining.
The PC1 column represents bottle 1 and PC2 column bottle 2
(each bottle 380 mL approximately 2 mL per cycle PC/CC
consumption).
CC1/CC2 in % The blue bar displays the amount of CleanCell (CC)
remaining. The CC1 column represents bottle 1 and CC2
column bottle 2 (each bottle 380 mL — approximately 2 mL
per cycle PC/CC consumption).
Ensure that ProCell and CleanCell caps are open before
starting a reagent scan.
Solid waste (actual no.) The blue bar displays the quantity of solid waste present in the
solid waste container. If the number exceeds 1100, the color
changes from green to red (waste capacity: 1100 tips and
cups)
Cup (actual no.) The blue bar displays the quantity of Cup trays remaining
(3 cup trays, 60 cups per each tray)
Tip (actual no.) The blue bar displays the quantity of Tip trays remaining
(3 tip trays, 120 tips per each tray)

Liquid waste and system water container levels are not displayed due to technical
reasons. Nevertheless, instrument alarm appears if the container is full or empty.

Liquid waste

Error code Mechanism Alarm message Level Alarm description

24_01_01 Liquid waste Liquid waste container is full P.Stop The liquid waste tank is full.
24-01-01 Liquid waste detection, (mode 1-1)
24_02_01 Liquid waste tank Liquid waste container is missing E. Stop There is no liquid waste tank.
24-02-01 Liquid waste tank detection, (mode 1-1)

System water

Error code Mechanism Alarm message Level Alarm description

25_01_01 System water System water container is low or P.Stop The level of the system water goes down and is short.
empty System water level detection float SW, (mode 1-1)
25-01-01

Additional information can be displayed in the position of the test, for example,
registration time, type and date of calibration, remaining tests, and reagent expiry
date.

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Global buttons and screens

Reagent Detail screen

Global buttons and screens

Function and main menu buttons

A B C D

E F G H I
A To view reports in print buffer B To view temperature for the reagent rotor,
incubator, system reagent, and measuring
cell
C Display color corresponding to highest D To trigger a reagent scan
priority alarm
E To view two folders: Test selection, Data F To view detailed reagent information and to
Review screen add reagents manually
G To view three folders: Status, Calibrator, H To view six folders: Status, Run status,
Install screens Individual, Cumulative, Control, and Install
screens
I To view four folders: System, Maintenance,
Application, and Calculated Test. Screens

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Global buttons and screens

Global buttons

Stop screen
Use this screen to stop the processing at the end of the current mechanical cycle.
Confirmation is required.
All sampling and sample processing is stopped and results in process are lost.

Logoff screen
Use this screen to log off from the system and change operator, or to shut down the
system.
The system remains switched on and in operation after you have logged off.

Logon screen
If the system is in password protection mode, the Logon screen is displayed whenever
the system is switched on or whenever a logoff has been performed.
Operator ID:
Type the operator ID in the Operator ID text box (up to six characters).
Password:
The password can consist of up to eight letters or numbers. The password is defined
the first time an operator ID is used.
There are three access levels:

Administrator level: Allows access to all screens

Operator levels: Allows access to screens necessary for routine operation

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Global buttons and screens

Sample Stop screen

Use this screen to perform a sample stop. Confirmation is required.
During a sample stop, the pipetter stops processing new samples. All other functions
related to test processing continue until results are available.
A sample stop can be performed only when the system is in operation. When Sample
Stop is activated, there is a yellow bar displayed.
The STAT rack information tab is for rack systems only.

Alarm screen
Use this list to view all alarms issued.
The alarm list can be sorted by any of its five columns: Code, Source, Level, Alarm
(Name), and Date/Time. A blue background distinguishes the selected column tab.
It can also be accessed from this screen, if an alarm indicates that maintenance is
required. Instrument alarms are only displayed in the software.

Code This column displays the alarm code and sub code.
Choose the tab to sort the list numerically by alarm code.

Source This column displays the source of the alarm.

Choose the tab to sort the list by the source.

Level This column displays the level of each alarm.

Choose the tab to sort by alarm level, with the highest level alarms displayed first
(E.Stop, Stop, S.Stop, or Caution).

Alarm This column displays the name of the alarm.

Choose the tab to sort the list alphabetically by alarm name.

Date/Time This column displays the date and time the alarm occurred. Choose the tab to sort the
list by date and time.

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Global buttons and screens

Description and Remedy This list displays the alarm Code, Sub code, description, and remedy for the selected
alarm.
Follow the steps in the section to troubleshoot the alarm.

Delete Use this button to delete the alarm selected in the Alarm list.

New Alarm If a new alarm occurs, this button turns yellow or red, according to the alarm level.
After the New Alarm button is chosen, the screen is refreshed and the new alarm(s) is
displayed.

Sound Use this button to turn the Sound on or off.

Maint. If maintenance is required, use this button to access the maintenance functions.

Print screen
The Print screen displays the tabs: Workplace, Reagent, Calibration, QC, and Utility.
Selecting one of these tabs displays the available corresponding reports.
Select the report to be printed or viewed from the list. Some reports may require that
specific parameters be defined before they can be viewed or printed.

Reports:
Several reports are generated from the system.
The date and time the report was printed is displayed in the upper right corner of
each report. Some reports are printed automatically by the system, whereas others are
selected manually from the global Print screen.

Workplace o Result Report (normal with/without signals, condensed)

o Worklist
o Status Report (sample tracking)

Reagent o Inventory List (system overview)

o Reagent Load (reagent unload list)

Calibration o Calib/QC Load List

o Calibration Trace
o Calibration Result

QC o Calib/QC Load List

o Control definition
o Individual QC Chart (list is included)
o Individual QC List (list is included)
o Cumulative QC Chart
o Cumulative QC List

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Global buttons and screens

Utility o Alarm Trace (daily and cumulative)

o Communication Trace
o Operator ID Trace
o Application Parameters List
o Test Conditions
o Maintenance Report

Start screen
Use this screen to define or request operating parameters such as host
communication, sample reception mode, and (for disk systems only) the sample disk
number.

Disk No. Shows the number of the current sample disk (for disk systems only).

Host Setting area: Choose On or Off to select or deselect host communication.

Choose OK to accept the change, or choose Cancel to close it without any changes.

Sample Reception Mode area If the mode is enabled on the Utility > System screen, the Hours box here on the Start
Conditions screen shows the duration of the sample reception mode.
The interval can be set to 1, 2, 4, or 8 hours. The programmed time interval
automatically restarts if a rack is inserted before the rack reception mode is elapsed.
For an analysis started with active Sample Reception Mode, the system remains in
operation after the last available sample is processed.

Pre-operation Operation Standby

Test Rack Test Rack
processing reception processing reception

Rack reception
START RE-START timer setting

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Workplace/Test Selection

Workplace menu
Use the Workplace menu to make test selections, specify patient information, assign
patient ID numbers and position numbers to samples, as well as review, backup, edit,
delete, and send data to the host.
The Workplace menu consists of the following two screens:
o Test selection
o Data Review

Workplace/Test Selection

Use this screen to enter test selections and information for a sample.
The way it works varies, depending whether STAT or routine test selections are being
entered and whether or not the system is operating in barcode mode.
After entries have been made on the Test Selection screen, the Save button turns
yellow.

Sample area Use this area to select the sample priority for which details are to be entered. This
function is available both in barcode and non-barcode mode.

Routine Select this option to enter test selections for a routine sample.

Stat Select this option to enter test selections for a STAT sample.

Rerun Select this option to enter test selections for a rerun sample.

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Workplace/Test Selection

Fields

Type Use this list box to select the sample type used (Ser/Pl (serum/plasma), Urine, or
Other).

Sequence No. Use this text box to enter the sequence number.
(non-barcode mode)
The sequence number is used by the system to associate test selections to a sample
when the system is operating in non-barcode mode.
Type a sequence number in the text box (1 to 9999) and press Enter.

Disk No. - Pos. Use these text boxes to enter the disk number and the position of the sample tube on
(non-barcode mode) the disk. Afterwards, press Enter.

Disk No. - Pos. Type the position number (1 to 30) corresponding to the sample position on the disk
(non-barcode mode) and press Enter.

Type the position number (1 to 5) corresponding to the sample position in the rack
and press Enter.

Rack No. - Pos. Use these text boxes to enter the rack number and the position of the sample tube in
(non-barcode mode) the rack. Afterwards, press Enter.
When loading samples in racks, make sure that the samples placed correspond with
the positions entered on the screen.

Sample ID Use this text box to define a sample ID number of up to 22 characters and press Enter.
If the system is connected to a host, this information is downloaded automatically
and no entry is necessary.

Pre-dilution Select On if the sample has been manually diluted, otherwise select Off.

Dead volume Select Normal or Reduced minimum sample volume. The default setting is Normal. A
reduced minimum sample volume can be set when using standard cups, loaded either
directly on the sample disk or rack or on top of a primary sample tube.

Sample Volume/Dilution Use this option to select the concentration for the current sample (Normal or the
required dilution). Application-specific dilutions are performed automatically by the
system.
To apply sample volume or dilution to a test, first select the required volume/dilution
and then select the test. If a sample is analyzed with several tests, a different volume
can be defined for each test performed.

Sample Status This box displays the status of the selected sample. Possible statuses include the
following:

Occupied Sample registered by user or host and the tests are not
aspirated, or there is still a test requested.
Processing Sample ID or rack ID has been read by the system.

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Workplace/Test Selection

Incomplete Samples processed, but a data alarm is present. No rerun

has been ordered.
Complete Samples successfully processed. All test results are
available without a data flag.
Sent to Host Sample results have been sent to the host.

The status of incomplete is not applied to control samples.

Sample volume This box displays the volume of the selected sample.

Test key colors and markings The test matrix area contains of 24 test keys. One test or profile is assigned to each key.
The test keys display special markings, according to the status or programming of the
associated test. The different markings and their meanings are outlined below:

A blank test key indicates that no test is assigned.

A test key with a test or profile name and no masking indicators can be
requested. Further settings are not required.
A white test key indicates that the test has been selected.

A yellow test key indicates that this test has been performed, a result is
available, and can be reordered again.
A red bar on the key indicates the test is automatically masked by the system.
The volume of reagent, or diluent, that is required for the respective test is
either insufficient or the reagent is not present on the system. The test can be
requested; however, the test is performed only if a new reagent bottle is placed
on the system.
A purple bar on the key indicates the test is automatically masked by the
system due to a failed calibration and the test requires a reagent pack or lot
calibration, or a new application was added to the system without performing
a calibration.
Setting has to be done before starting the routine under Utility/Applications.
A white triangle pointing down indicates a test is marked to be run with a
dilution. The number after the triangle indicates the ratio of the dilution (for
example, 2 represents 1:2).
A brown bar on the key indicates the key has been assigned a profile. When
selected, all tests assigned to that profile are highlighted.

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Workplace/Data Review

Workplace/Data Review

Use this screen to review and validate routine and STAT results. Control results can
also be viewed here. Other tasks that can be performed from this screen include
editing sample information, searching for a sample, sending data to the host, deleting
data individually or in batches, and backing up data.

Filter area Data can be filtered by criteria defined on Workplace > Data Review > Filter.
Select the On or Off options in the Filter area to switch the filter on or off respectively.

Data area The information can be displayed from either the Routine View or the QC view.
Use this list box to select the source from which data is to be read.

Routine View Select this option to show all samples in the database. This is the default.
In total 2000 tests (STAT, Routine) and controls can be stored. The database is
updated whenever a new sample data is coming in.

QC View Select this option to display control data in the sample selection list. The data
displayed has been deleted from the database.
Take care; backup data from QC View is not possible.

Clear sample data Performing a Delete All deletes all patient results currently stored in the database and
moves any control results to the QC View.

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Workplace/Data Review

Sample selection list This list on the left side of the screen displays the samples registered by the system.
The content of the list varies, according to whether Barcode or non-barcode mode is
selected on Utility > System.
The sample selection list consists of seven columns that can be sorted by S. No.,
Sample ID, the main comment, and Pipetting Date/Time.
A white background distinguishes the selected column tab.

St. This column displays the sample status codes.

O (Ordered) A sample has been registered by the user or host and a test requested, but the test has
not yet been run or at least one of the test results has a data flag.

P (Processing) The sample ID or rack ID has been read by the barcode reader.

I (Incomplete) The sample has been processed, but a data alarm is present. No rerun has been
ordered.
This status is displayed as well if flags are defined in the Review by Exception window.
The sample ID remains on the screen until the operator validates the results and sends
them to the host.
The status of incomplete is not applied to control samples.

No symbol (Complete) The sample has been processed successfully without any data flags.

H (Sent to host) The results of the sample have been sent to the host.

S. No. Choose this tab to sort and display the sample selection list by sequence number. The
column below the tab displays how the sample was run, N for normal or routine,
E for emergency or STAT, and C for control, and the sequence number of the sample.
For example, N00203 identifies the sample as a routine sample with sequence number
203.

Rack Displays the rack number and sample position within the rack for the current sample.

Sample ID Displays the sample ID. Choose this tab to sort the sample selection list by sample ID.

Pipetting Date/Time Choose this tab to sort the sample selection list by the date and time the samples were
pipetted.

Test results list This list is displayed on the right side of the screen, and displays the results of the tests
performed on the sample that is currently selected in the sample selection list.

Test This column displays the test processed for the currently selected sample. If the
sample status is Ordered or Processing, a symbol is displayed in the St (sample status)
column on the left side of the screen.
A white triangle indicates that a test is marked to be run with a dilution, and is
displayed on the Test Review screen.

Result Displays the first result of each test for the selected sample.

Unit Displays the measurement units (for example, pmol/L or nmol/L) for the listed
sample.

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Workplace/Data Review

Alarm Displays any data flag associated with the result of any test for the selected sample.

Comment Display the Comment screen; any comment can be entered about the selected sample.
This button is only active after a sample ID (barcode mode) or a Rack ID and Position
(non-barcode mode) has been entered.

Search Sample screen Use to search for a sample in the database.

The sequence number and sample number search criteria can be defined.

Filter screen

Use this window to define filter criteria used to filter the information displayed in the
sample selection list.

Sample area Use this area to filter results by sample type. The available options are: Routine, STAT,
Control, and Rerun.

Sample Status area Use this area to filter results by status of sample processing. The available options are:
Ordered, Processing, Completed, and Incomplete (draft screen version).

Type area Use this area to filter results by sample material. The available options are: Ser/Pl
(serum/urine), Urine, and Other.

Documented Status area Use this area to filter results by whether they have been documented. The available
options are: Documented or Not Documented.

Pipetting Date Use this option to filter results within a defined pipetting date range. To define the
range, type the start date in the first three text boxes and the end date in the final three
text boxes.

Pipetting Time Use this option to filter results within a defined pipetting time range. To define the
range, type the start time in the first two text boxes and the end time in the final two
text boxes.

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Workplace/Data Review

Send to Host

Use this window to send data to the host. Either all or specific types of sample results
can be transmitted to the host.

Data Selection area Highlight the samples to be sent to the host in the sample list on Workplace > Data
Review; then choose Send To Host.

All Data Select this option to send all data to the host.

Not Send Host Select this option to send only results that have not already been documented to the
host.

Review by Exception Results Select On to send results to the host even if they are flagged with a data alarm,
otherwise select Off. The data alarms that normally prevent a result from being sent
to the host are listed under Utility > System > Review By Exception.

Send Use this button to start the transmission of the specified sample results to the host.
After transmission, the status for the selected sample changes to H (Sent to host) on
the Data Review screen, indicating that the results of the sample have been
successfully sent to the host.

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Workplace/Data Review

Backup Data

Use this screen to make a backup copy of results selected in the sample list on
Workplace > Data Review.

Target Device Choose Internal to back up data to internal memory only. Choose External to copy
the data to the external memory device (DVD).

Folder Name Type a folder name in the text box (for example, date, time, samples, control ID).
After confirmation that the backup process has started, the message IN PROCESS,
PLEASE WAIT is displayed. Wait until this message disappears before continuing.

Delete Record To hide sample records in the Routine View, highlight the samples which are no
longer displayed in the Data Review screen.
This function does not delete the sample records in the Routine View. It only hides
the records and moves the QC data into the QC View screen.

Delete All Use the button to delete all patient samples (Routine/STAT samples and test requests)
and move the QC data into QC View screen.

Test Review

Use this screen to displays detailed information regarding the first results and rerun
test results. The sample has be marked on the Data Review screen.

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Workplace/Data Review

Sample This box displays the sample type (for example, STAT, Routine, or Control) of the
sample selected on Workplace > Data Review.

Sequence No. Displays the sequence number of the sample selected on Workplace > Data Review.

Disk Displays the Disk ID and position (1 to 30) on the disk where the sample selected on
Workplace > Data Review is located.

Rack No./Pos. Displays the Rack ID and position (1 to 5) where the sample selected on Workplace >
Data Review is located.

Type Displays the sample material of the sample selected on Workplace > Data Review.

Sample ID Displays the sample ID number.

Sample Status Displays the sample status (Ordered, Processing, Complete, Incomplete or Send to
Host)

Test result list

For each of the results (first result and rerun result) the following information is
displayed:

Test This column displays the short name of the test. If both the first and rerun result are
available, operators can select the result to report.

Result This column displays the test result.

Unit This column displays the measurement units (such as, uIU/mL, mmol/L, or mg/dL).

Alarm This column displays any data alarms associated with test result.

R.M. This column displays a result message (R.M.). Reactive (r), non-reactive (n) or
borderline (b) indicates if a test for an infectious disease (qualitative assay) has a
positive or negative result, respectively.

Dil. This column displays the sample dilution ratio used to produce the test result.

Date This column displays the date the test was pipetted.

Time This column displays the time the test was sampled.

St. This column displays the status code of the test result. O (Ordered), P (Processing),
I (Incomplete), No symbol (Complete), H (Sent to host). These statuses are described
under workplace/Data Review.

Signal Displays the effective signal measured.

Reagent Lot Displays the lot number of the reagent used for the test.

Pos Displays the position of the sample selected on Workplace > Data Review.

R.P.No This column displays the reagent pack number of the reagent used for the test.

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Workplace/Data Review

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Reagent

Reagent menu

Reagent

Use this screen to view details of reagents currently loaded on the system, manually
register a reagent, and perform a reagent scan.

Reagent data list This list displays the reagent data for the reagents currently loaded on the analyzer.

Pos. Displays the positions of the reagents on the analyzer.

The following symbol, displayed in the legend below the Setting screen list, may
appear to the left of the position number:
* Manual Setting
An asterisk (*) on the left of Pos (the position number) indicates that the reagent has
been manually registered.

Test Displays the short test name of the reagent currently loaded in the corresponding
reagent position. Question marks appear in this column when a reagent barcode is
registered by the barcode reader and the application parameters are not on the
system. The test names are highlighted to indicate alarms.
The following colors are possible:

Yellow Amount of reagent is below the yellow alarm level.

Red There is no more reagent available for this test, or the reagent is missing.

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Reagent

Reagent type This column displays the type of reagent. The following table displays the reagent
types:

Type Description
ASSAY Assay reagent pack
DIL Diluent reagent pack
PRE Pre-treatment reagent pack

Remaining Determinations This column displays the number of determinations remaining for the corresponding
reagent.

Lot No. This column displays the lot number of the reagent in the corresponding reagent
rotor position.

Reagent Pack Number This column displays the reagent pack number (the unique number on the reagent
bottle label that identifies the reagent pack) of the reagent in the corresponding
position.

Expiration Date This column displays the expiration date of the reagent in the corresponding position.
The first two numbers represent the year, while the last two represent the month. If
the reagent has already expired, this column is highlighted red.
Expired reagents flags are displayed in:
o Reagent Load
o Workplace/Data Review screen (with the flag ¥)
o Data flag - ReagEx is attached to the result

Reagent inventory list Use this list to view the system reagents levels.

Type Displays the type of consumable. The following colors are possible:

Yellow o One of the two CleanCell or ProCell bottles are <20%

o Only one Tip or Cup tray left
Red o Both of the two CleanCell or ProCell bottles are <20%
o There are no Tip or Cup trays left
o The solid waste tray is full

Position Displays which position on the system, the system reagent bottle is in (1 or 2).

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Reagent

A B

C D E F
A Set 2 B Set 1
C Position 4 D Position 3
E Position 2 F Position 1

Lot No. Displays the system reagent lot number, if required.

Remaining Volume Displays the amount of the consumable remaining, expressed in mL or number of
items. When empty, a red “0” is displayed in this column.

Inventory Set Use this window to specify the lot number for ProCell loaded on the analyzer.

System Reagent area Use this area to enter the ProCell lot numbers for the corresponding positions
(1 or 2).
This area contains two text boxes: ProCell Position 1 Lot Number and ProCell
Position 2 Lot Number.

Reagent Scan screen Use this window to perform a scan of the barcodes of the reagents loaded on the
system and refresh the Reagent screen. Choose OK to perform a reagent scan.
Cancel closes the window without performing a reagent scan.

Manual Registration screen Use this window to register a reagent pack manually to the position currently selected
in the list on the Reagent screen.

Reagent Rotor Position No. Displays the number of the reagent rotor containing the reagent pack to be registered
manually.

Reagent Pack ID Use this text box to enter the number of a Roche Diagnostics reagent pack. The
number is printed on the barcode label of the bottle.

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Reagent

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Status

Calibration menu
From the Calibration menu, tests can be viewed which are required and requested for
a calibration. In addition, you can view the measured results and the reaction curves
of current, valid calibrations. Information about calibrations is also entered from this
menu.
The Calibration menu consists of three buttons:
o Status
Used to select tests for failed, timeout, repeat, changeover, or manual calibrations,
view the calibration results, and monitor the calibration
o Calibrator
Used to view and assign calibrator positions.
o Install
Used to add and delete calibrators from the system.

Status

Calibration Status The timeout period for an assay is automatically reset when a successful calibration is
performed. The timeout period for an assay is not reset when a calibration fails.
In the event of a failed calibration, the system reverts to the last successful calibration
to calculate patient and control results according to your system setting.

Status list The status list in the centre of the screen consists of six columns showing detailed
information about the calibration status of the tests.

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Status

Position Displays the reagent position on the instrument.

Test Displays the test name. Choose the tab (column header) to sort the list by test name.

Status Displays each reagent's status of precedence. Currently used reagents are indicated by
Current, standby reagents are indicated by Standby.
The order of precedence of standby reagents within the same lot is assessed by:
o Reagent pack with the current lot number
o Reagent pack lot which is expires first
o Within same lot., reagent pack with oldest registration date is used
o Reagent pack with lowest filling level is used
o Reagent pack on lowest position

Calib. Type Displays whether a calibration is a lot calibration (Lot) or a reagent pack calibration
(R.Pack). For recommended calibrations (highlighted in green) and requested
calibrations (highlighted in blue), the entry in under Calib. Type refers to the
upcoming calibration.
After a calibration is successfully generated, when Calib. method and Cause are blank,
the entry in under Calib. Type refers to the existing calibration.

Select Displays the whether the full calibration method has been selected for a test in this
position. When the calibration is highlighted green, the system has suggested this test
for full calibration.

Cause Displays the reason for the calibration to be carried out. Possible reasons include
Changeover, Failed, Timeout, QC Violation, and Manual.
$Cause Occurrence
Changeover A changeover is triggered when:
o A new test is installed or
o A new lot for that specific reagent pack/tests is added to the
system
o The reagent pack which is registered, has a invalid calibrations
Failed When a calibration has failed and needs to be repeated because of one
of the following:
o Failed due to calibration criteria not being fulfilled
o Hardware issue
Timeout When the timeout period of the reagent is exceeded, the timeout is
reset after a valid calibration. (Lot calibration 28 days is over, reagent
pack calibration 7 days is over).
o For each tests the time out reagent pack calibration stability is
defined and encoded the reagent pack barcode label
o For a few test the calibration has to be done daily

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Status

Cause Occurrence
QC Violation When the test is configured for:
o QC-triggered calibration and
o A QC result falls out of the confidence range specified for this test
Manual Calibration can be ordered or deselected manually by the operator.
Reject When a calibration fails, the corresponding table line is highlighted in
red.
o If auto masking is activated, no control or patient sample can be
measured with this reagent. Using the Reject button, in this case,
unmasks the test; results are calculated with the previous
calibration curve and no Calib alarm is attached to the results.
o If auto masking is not activated, controls and patient samples are
measured but the results are calculated with the previous
calibration curve and a Calib alarm is attached to the results.
Using the Reject button, in this case, deletes the calibration
recommendation and no Calib alarm is attached to the results.

Calibration causes Auto masking Consequence

Failed change over ON No pipetting of controls and
calibration samples

Failed OFF Pipetting of reagent, result

(previous calibration calculation with previous valid
is available) curve CalErr flag
Change over request OFF Pipetting of reagent, no result
(because of a new lot calculation
- different calibrator
target values for
different reagent lots)

Calibration Trace

Use this window to view the calibration signals of the 50 most recent calibrations for a
specific test.

Calibrator Displays the calibrator type for the selected calibration, either Calibrator 1
(minimum) or Calibrator 2 (maximum).

No. Displays the vial number of the calibrator (level 1 and level 2) selected in the
calibration trace below.

Signal Displays the measured signal count data for the selected calibration.

Alarm Displays the alarm code for the selected calibration, if applicable. An asterisk (*) is
displayed next to the code if the alarm occurred while the calibrator was being
measured.

Date Displays the date when the selected calibration was performed.

Time Displays the time of the day when the selected calibration was performed.

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Status

Reagent Lot No. Displays the lot number of the reagent used to perform the selected calibration.

RP No. Displays the reagent pack number of the reagent used for the selected calibration.

Graph area The minimum and maximum standard count values, and calibrator and slope values,
are displayed using the left and the right Y-axes respectively. They can be scaled
independently or set automatically on the Scale Setting window.
o The points on the calibration curve for the minimum standard Std(min),
representing Cal1 (calibrator 1), are illustrated by a ( ).
o The points on the calibration curve for the maximum standard Std(max),
representing Cal2 (calibrator 2), are illustrated by a ( ).
The scaling factors can be adjusted with the Scale button.

Automatic Select the Automatic option to display the calibration trace with automatic scale
settings. In this case, the system determines the appropriate scale setting necessary to
display the calibration values automatically.

Manual For all tests, type values for the lower and upper limits of the scale, in counts (-999999
to 999999), for both minimum Std (min) and maximum standard Std (max), using
the corresponding text boxes.

Comment Use this window to enter a user-defined comment of up to 600 characters for the
selected calibration. Comments entered here will be included in the Calibration Trace
report. If a comment has been added to the selected calibration, this button is yellow.

Factors list The factors correspond to the slope (factor a) and the intercept (factor b) of the graph
defined by the linear equation, Y = aX + b.
This area contains two text boxes that display the values for the test combination
currently selected in the factors list. To alter the values for a specific test combination,
select the appropriate entry in the factors list and type the new values for a and b in
the corresponding text boxes.
o a Is used to enter the value for factor a (slope)
o b Is used to enter the value for factor b (intercept)

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Status

Calibration Result window

Quantitative assays

Qualitative assays

Calibration Quality Criteria for quantitative tests

Min (minimum signal) The measured signal of the calibrator replicate must be above the minimum value.
Values are test dependent and are encoded in the reagent barcode.
If one or more calibrators are below the recommended minimum signal level, the
calibration is failed (red).

Missing values Duplicate determinations of two calibrators are used to adjust the master calibration
curve stored on the reagent pack barcode.
If one of more calibrators is missing, the calibration is failed (red).

Monotony All measured calibrator values must fall in ascending (sandwich or bridging
(quantitative assays only) principle) or descending (competition principle) order. This is termed monotony.

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Status

If the monotony is not given, than the calibration is red.

Diff. The minimum acceptable difference is defined as the difference in percent of the
values between calibrator 1 and 2. This difference must amount to at least 30% for the
calibration to be accepted.
The difference between the negative and positive calibrator signal values must be
greater than the allowable value limit. This limit is test dependent and is encoded in
the reagent barcode.
The minimum acceptable difference is listed as OK or NG (Not Good).

Dupl. The deviation of duplicate measurements is a check of the signal values for each
replicate of a calibrator.
If the difference between the duplicate measurements of one or more calibrator level
is too high (in general > 10%), the calibration is failed (red).
The signal values are used to calculate the mean value of the duplicate measurements

Sys. Err. A hardware error occurred during a calibrator measurement.

If either 1 (Cal 1) or 2 (Cal 2) appear in this field, the result is a failed calibration
(red).

Factor A curve position check against the most recent lot calibration produces a calibration
(quantitative assays only) factor. This field displays a number that represents this factor.
Each new lot calibration (L-Cal) utilizes a calibration factor of 1. For all subsequent
reagent pack calibrations (R-Cal), a new calibration factor is calculated.
The calibration factor is the quotient of the slopes of the actual performed calibration
and the related stored calibration.
The calibration factor is only used as calibration validation criteria and not used for
sample calculation.
Successful calibration range: 0.8 - 1.2
Red calibration range: < 0.8 or > 1.2

The calibration factor criterion is only used in validating R-Cals.

Calibration Quality Criteria for qualitative tests

The previous mentioned criteria also apply to the qualitative assays and in addition
one calibration Quality Criteria will be 'validated':

MIN/MAX (minimum/ The measured signal of the calibrator should fall between the designated minimum
maximum signal) and maximum signal. Minimum and maximum signals are test dependent and are
encoded in the reagent barcode.
If one or more signals are out of the allowable minimum/maximum signal range, the
calibration is failed (red).

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Calibrator

Calibrator

Calibrator list Use this screen to view and assign calibrator positions. This list displays the position
assigned to the calibrator, the calibrator name, code number, lot number, and
expiration date. It can be sorted by calibrator name or rack number.
A white background distinguishes the selected column tab.

Calibrator Displays the test name and calibrator level (for example, T4-L2 for an Elecsys test
name T4, calibrator level 2).

Position Displays the rack/disk number and position of the calibrator (for example, 1234-3 for
rack/disk no. 1234, position 3). Choose the tab to sort the list by position number.

Calibrator Lot No. Displays the lot number of the calibrator.

Expiration Displays the expiration date of the calibrator lot.

If the Expiration column is highlighted in red, the corresponding calibrator has
expired and cannot be used anymore.

Position Assignment Display the Calibrator Rack Assignment screen. This window is used to assign a
position to a calibrator, for example, if the calibrator barcode is unreadable.

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Install

Install

Install screen

The Install screen is used to add and delete calibrators from the system. The calibrator
list box displays information for all calibrators entered in the system.

No. Displays the number of calibrators on the system.

Up to 160 calibrators can be installed by BC Card or by a Download process.
The calibrator information is transferred via the Calibrator Barcode Card.
Target values are not displayed on the screen, but will be displayed on the Calibration/
Status/Calibration Result screen, when a calibration was performed.

Calibrator o Displays the name of each calibrator. Calibrators are test specific.
o The numbers of determinations per calibrator are two vials.

Calibrator Lot No. o Displays the lot number of each calibrator per tests.
o Only one lot number can be installed for a test.

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Quality Control menu

From the Quality Control menu you can view which controls can be viewed, which
need to be measured, and requesting can be done for the measurement. In addition,
quality control measurement results can be displayed, accumulated to the cumulative
quality control, and statistical rules applied.
Control target values, which are specified in the package inserts, can be installed,
edited, or deleted from this menu.
The Control menu consists of six buttons:
o Status
Used to view information on quality controls status and select them. Stand by
reagent packs to be controlled can also be selected.
o Run Status
Used to get an overview of the last 500 QC measurements and to view the most
recent QC measurements for one particular test specified.
o Individual
Used to view a list of all daily QC results, to display QC chart, to accumulate QC
results, to comment, and to exclude it.
o Cumulative
Used to view a list of all accumulated QC results, to display the Levey-Jennings
chart for accumulated QC points, and to delete accumulated data.
o Control
Used to view assigned control rack or disk numbers and positions and to assign
positions to non-barcode controls vials.
o Install
To scan in control barcode information, to manually add and delete controls from
the system, and to assign control.

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Status

Status

The Status screen is used to view information on quality controls status and select
them. From this screen, stand by reagent packs can also selected. This list displays
information about controls currently active on the system. A blue background
distinguishes the selected row.

Test Displays the short test name of a test on board that has been activated in the Install
screen for QC.

Control Displays the name of the control used for the test. Choose the tab to sort the status list
by control name.

Control Lot No Displays the lot number of the control used for the selected test.

Selection Displays a green bar with a tick (l) when the corresponding test has been selected for
QC. To select or deselect a test, highlight the row corresponding to the test you wish
to select; then use the Select/Deselect button.

Cause Displays the cause for the QC selection.

If the test has been selected manually (using the Select/Deselect button), a green bar is
displayed in the Selection column and Manual is displayed.

Stand By Bottle QC screen Use this screen to select stand by reagent packs currently on the system for stand by
QC processing. All tests and controls for stand by reagent packs are displayed.
A blue background distinguishes the selected row.

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Run Status

Run Status

The Run Status screen is used to get an overview of the last 500 quality control (QC)
measurements or to view the most recent QC measurements for one particular test
specified.
Once the limit of 500 QC measurements is exceeded, existing QC measurement
results are overwritten starting with the oldest first.
Those results that exceed the user-definable confidence limit ± 3SD range can be
identified by various colors and symbols.

Quality control settings

There are two conditions under which the system automatically recommends that
calibrations and control measurements be performed:
o Quality control (QC) violation
If the control results exceed the confidence limit, a calibration request is
automatically recommended by the system. The QC results are displayed on the
Run Status screen.
o Timeout (Mean-3SD)
A calibration is recommended by the system after a certain time interval set for the
lot and reagent packs calibration timeout.

Test box Select a test from this list to view information on the most recent QC measurements
for one particular test.

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Run Status

QC run status details The Run Status screen consists of three areas:
o A details area in the upper part of the screen
o A run status chart in the centre of the screen
o A legend, which explains the symbols used on the chart.

Details area in the upper part of The details area in the upper part of the Run Status screen displays the following
the screen information, which relates to the QC measurement selected on the run status chart:
Control, Control Lot No., Test, Reagent Lot No., RP No., Pos., Status, Date, Time,
cl-high, cl-low, Result, Unit.
QC results that lie outside of the measuring range (for example, low control level for
infectious diseases) are not displayed in the run status screen. Nevertheless, a
calibration is recommended.

QC run status chart

The chart displays up to 500 results of QC measurements.

Background o A white background refers to today’s measurements.

o A blue background refers to past measurements (taken before midnight of the
previous day).

Shape o Circles are used when QC violation is activated.

o Triangles are used when QC violation is not activated (Timeout).

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Individual

Color o Red and yellow denote a QC result falling out of confidence limits or 3 SD limits,
respectively.
o Green symbols are used for results within the relevant limits.
The following symbols are used on the QC run status chart:

QC result exceeds confidence limit (right Y-axis of chart). A calibration is

automatically recommended for the affected test.

Today's QC result within confidence limits.

Past QC result within confidence limits.

QC result falls outside ± 3 SD (left axis of chart).

Today's QC result within ± 3 SD.

Past QC result within ± 3 SD.

Individual

The Individual screen is used to view a list of all non-accumulated QC results (daily
control results), to display QC charts, to accumulate QC results, and to delete QC
results.

Individual list The list can be sorted by the test name, and control name. A blue background
distinguishes the selected row.

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Individual

Test Displays the short name of the test.

Reagent Lot No. Displays the lot number of the reagent pack used for the QC.

Control Displays the name of the control used.

Sample Type This box displays the type of sample material tested (for example, Serum/Plasma).

Control Lot No. Displays the control lot number processed.

Target Mean Displays the control target mean as defined on QC > Install.

Target SD Displays the control target standard deviation as defined on QC > Install.

N Displays the number of QC runs carried out on this control since the last
accumulation.

Mean Displays the calculated mean of measurement result for the corresponding QC test.

SD Displays the standard deviation calculated from N observations for the corresponding
QC test.

CV(%) Displays the coefficient of variation calculated from the mean value and the standard
deviation for the corresponding QC test.

Individual QC Chart window

The Individual QC Chart window displays all recent values per test for each control.
The values are displayed in FIFO principle:
o Up to 3 control levels
o Maximum 180 target values (mean and SD) for each control level

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Individual

Chart list Displays detailed information for the point currently selected in the Levey- Jennings
chart:
Plot, Control, Control Lot No., S. Type, Result, Date and Time, N - Number of
control runs, Mean, SD, CV %.

Levey-Jennings chart

A Levey-Jennings chart provides a visual method of monitoring trends in quality

control results. The values, in SD (standard deviation) of the controls measured, are
plotted on the Y-axis and time on the X-axis.
All points should lie within the ±3SD range. If a point falls outside of this range,
corrective action is required. Up to three different controls for a single test can be
displayed on the chart.

Black: Comment has been attached to this point

White: The point has been excluded
Grey: The point has a comment and has been excluded

The controls are represented using the following graphic symbols:

Control 1 (include) Control 1 (exclude)

Control 2 (include) Control 2 (exclude)

Control 3 (include) Control 3 (exclude)

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Individual

Accumulate

Use this screen to accumulate the selected data to the long-term statistic (sub-menu
Cumulative).
The method (Mean-R or X-R), QC Calculation (Day-to-Day, Overall) can be selected
in Utility/System/QC Setting.
The selected results are accumulated depending on the method selected on Utility >
System - QC Setting and the Accumulate Data screen will appear differently for
Mean-R or X-R accumulations.
There are two ways in which to accumulate QC data into the long-term statistic:
Mean-R and X-R.

o If X-R is selected, only a single QC measurement is transferred to the long-term

statistic. The single QC result has to be selected for each accumulation.

o If Mean-R is selected, the mean value of the number of QC measurements is

transferred to the long-term statistic.

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Individual

QC calculation (only available for Mean-R accumulation method)

There are two possibilities for calculating the QC mean and SD for the long-term
statistic (QC/Cumulative screen), day-to-day, or overall.
o If Day-to-day calculation is used for the calculation of the SD for each
accumulated control result, the SD will be determined by treating all results
equally, regardless of how many points were used in each accumulation.
o If overall calculation is used for the calculation of the SD for each accumulated
control result, the SD will be determined by weighting results based on how many
points have been used in each accumulation.

Example QC calculation

Individual QC data
Day 1 Day 2 Day 3
20 21 20
19 22 21
19 19 19
20 20 -
- 20 -
n=4 n=5 n=3
Mean=19.5 Mean=20.4 Mean=20.3
SD=0.5 SD=1.0 SD=0.8

If Calculation (Day to Day) is selected:

Calculation (Day to Day) is

selected: + 20.4 + 20- = 19.96
Accumulated mean = 19.5
--------------------------------------
3

( 19.5 – 19.96 ) 2 + ( 20.4 – 19.96 ) 2 + ( 20.0 – 19.96 ) 2 = 0.45

Accumulated SD = ---------------------------------------------------------------------------------------------------------------------------
3–1

QC Calculation (Overall) is
selected:
Accumulated mean = (---------------------------------------------------------------------------------
19.5 × 4 ) + ( 20.4 × 5 ) + ( 20 × 3 ) = 20.0
12

2 2 2 2
ΣSD ( n – 1 ) = ( 0.5 × 3 ) + ( 1.0 × 4 ) + ( 0.8 × 2 ) = 6.03
2 2 2 2
Σn × mean = ( 4 × 19.5 ) + ( 5 × 20.4 ) + ( 3 × 20.0 ) = 4801.8
2
mean × n = 20 × 12 = 4800

6.03 + 4801.8 + 4800- = 0.84

Accumulated SD = --------------------------------------------------
12 – 1

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Cumulative

Cumulative

The Cumulative screen is used to view a list of all accumulated QC results, to display
the Levey-Jennings chart for accumulated QC points, and to delete accumulated data.

Cumulative list

It can be sorted by test name or control name. A blue background distinguishes the
selected row.

Test Displays the short name of the test.

Reagent Lot No. Displays the lot number of the reagent pack used for the QC.

Control Displays the name of the control used.

Sample Type This box displays the type of sample material tested (for example, Serum/Plasma).

Control Lot No. Displays the control lot number processed.

Target Mean Displays the control target mean as defined on QC > Install.

Target SD Displays the control target standard deviation as defined on QC > Install.

N Displays the number of accumulations (maximum of 500).

Mean Displays the accumulated mean for each test displayed using the accumulation
method selected on Utility > System QC Setting.

Unit Displays the unit of measurement used for the test, for example, pmol/L.

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Control

SD Displays the standard deviation. The SD is the measured result calculated from N
observations for each test.

CV(%) Displays the coefficient of variation. The CV(%) is calculated from the mean value
and the standard deviation for each test.

Use this screen to view the Levey-Jennings chart for accumulated QC points for each
test and QC evaluation rules. Depending on the QC setting on Utility > System > QC
Setting, the chart looks different.
The range plot shows the range between the accumulated data.

Cumulative QC Chart screen

o Up to 3 control levels
o Maximum 500 for numbers of accumulations include all tests

Chart list Displays detailed information for the point currently selected in the Levey- Jennings
chart: Plot, Control, Control Lot No., S. Type, Result, Unit, Date and Time, N -
Number of control runs, Mean, SD, and CV %

Range Plot If selected, a second graph is displayed on the cumulative QC chart. This plot shows
the range of individual results in each accumulation. The bottom line represents zero,
or no deviation. The centre line is 3x the target SD and the top line is 6x the target SD.

Control

Control list

Use this screen to view assigned control rack or disk numbers and positions and to
assign positions to non-barcode controls.
This list displays the rack/disk number and position to which the control is assigned,
the control name, sample type, control lot number and expiration date.

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Control

Control Displays the control name. Choose the tab to sort the list by control name.

Position Displays the rack/disk number and the position of the control within the rack/disk
(for example, 0123-3, for control rack - disk number 3, position 3).
Choose the tab (column header) to sort the list by position.

S.Type Displays the sample type assigned to the control.

Calibrator Lot No. Displays the lot number of the control.

Expiration Displays the expiration date of the control. Expired controls show a red background.

Position Assignment Display the Control Rack Assignment screen. This window is used to assign a position
to a control, for example, if the control barcode is unreadable.

Ensure sufficient control volume

In non-barcode mode, the system cannot calculate the remaining volume in the control vial or cup.
Ensure that sufficient control material is available.

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Install

Install screen

Use this screen to scan in control barcode information or manually add and delete
controls from the system, to assign control values, and to activate or deactivate a test.

Control list
This list displays all controls that are installed on the system. For all installed controls,
the control name is highlighted in blue.

No Displays the number of calibrators on the system.

o Up to 100 controls can be installed by BC Card or by a Download process
o Multiple controls can be used
o Barcode and NON-Roche controls can be used
o The control information for Roche Controls is transferred via the Control
Barcode Card or entered manually for NON Roche controls

Control o Displays the name of the control

S. Type o Displays the sample type assigned to the control

Control Lot Number o Displays the lot number of controls

The QC number range from 0 to 63 is for Roche controls, whereas the range from 64 to 78 is for
NON-Roche control.

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Test list
This list, displays details about the tests assigned to the control selected from the
control list on the left. Choose the required tab to display information relating to
individual QC values, cumulative QC values, or high/Low QC confidence limits.

Add Control Use this screen to add a control or edit the target values of a registered Roche control.
If you try to add a control that is already defined on the system, a warning message is
displayed. A Material Code can only be registered once.

Read Control Barcode Card Used to start a barcode scan of Roche controls, read the control target values, and
enter them on the system automatically.

Download Under investigation (via cobas Link)

Edit Control Use this screen to define target values and confidence limits for the tests covered by
the control selected on the QC > Install screen.
If changed manually, these target values take priority, and are used until the next
control lot number is loaded.

Active Test/Inactive Test Use this button to activate or inactivate the selected test for the selected control.
This button switches between Active Test and Inactive Test, according to the
operator's choice. Inactive control values remain in the system but do not display on
the QC charts. Activated controls and tests are highlighted blue.

Individual area
Displays the individual target mean and target SD previously assigned.

Cumulative area
Displays the cumulative target mean and target SD previously assigned.

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Confidence limit area

Confidence limits are automatically calculated whenever target and SD values are read
from the barcode card.
If target and SD values are entered manually (for example, NON-Roche QCs) the
calculation of confidence limits is achieved by choosing the Calculate button.
However, confidence limits can also be typed directly in the text boxes under
Confidence Limit.

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Edit control screen

Confidence Limit High Used to edit the upper confidence limit of the selected test.

Confidence Limit High Used to edit the lower confidence limit of the selected test.

Calculate Used to calculate the confidence limits whenever the QC target value or SD is edited
or entered manually.
This field is not available if the concerned test is not configured for QC Violation, or if
it does not use the control that is currently being edited.
The target value and SD is manually entered and therefore the calculation of
Confidence interval has to be performed manually by pressing the calculate button.
This is indicated by a yellow calculate button.
The confidence limit itself can also be entered manually.

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System

Utility menu
The Utility menu consists of four screens:
o System
Used to define system parameters
o Maintenance (separate document)
Used to carry out maintenance regularly, reset system function in case of trouble
o Application
Used to view, added and updates application parameters
o Calc.Test
Used to define calculated test formulas. A calculated test result is not actually
performed on the system, but is calculated from other test results

System

The System screen has three pages of function buttons. The Page button is located in
the lower right of the screen and is used to successively view each of these pages.

Sample Tracking (disk system)

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System

Sample Tracking (rack system)

Date and Time Setting area

Date Format Used to select the date format used by the system. The following formats can be
selected: dd/mm/yy, mm/dd/yyyy, yyyy/dd/mm, yyyy/mm/dd
(d = day digit, m = month digit, y= year digit).
The system uses the format set here for all screen displays and printouts.

Set Date/Time Use to define the date and time. The year is indicated as four numbers. The time is
entered in 24-hour format.

Screen Saver area

Use to switch the screen saver on or off. If the screen saver is switched on, the interval
can be set by typing the number of minutes used as the screen saver interval (1 to 60)
in the text box.
The screen saver is automatically activated if no activity has occurred for the specified
time interval.

Test Name Order area

Use this area to select the order in which tests are listed on Utility > Application.
Select Name to order test in alphabetical order according to the test name. Select Test
No. to order test in the sequence in which they displayed under the Application/
Range/User Test no.
The User/Test no. is also used for Host communication setting.

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Rack Assignment area

(rack systems only)

Displays information about the rack ranges for the rack number. The first column
displays the sample, calibrator and control information, and the second to third
columns display the rack number ranges assigned to each type.
Selection of Rack Ranges is an option, but not mandatory.
Only one common rack (grey color) is used for all the range type settings.

Barcode Setting area

A barcode read error messages is displayed for a non bar-coded/misreading sample in
the alarm screen, if Yes is selected. The sample is also flagged in the Sample Tracking
screen. Nevertheless, the sample will measured according to Elecsys 2010 hardware
guidelines.

Printing Page Size area

Use this area to select the page size for all printouts. Possible selections are A4 (21 cm
x 29.7 cm) and 8 ½" x 11".

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Sample disk mode area

(disk systems only)
Use to set the sample disk mode to either Single or Multiple. In multiple disk mode,
ten (0-9) different sample disks can be used. Settings have to be done before starting
routine. If settings are changed later, the following topics have to be considered:
1. Test selection which is not measured
2. Calibration/control position assignment
3. Sample tracking information
The disk number to be used for a run can changed under the Start Conditions screen.
Disk numbers are displayed in result reports.

Sample Reception Mode area

The sample Reception mode interval can be set to 1, 2, 4, 8, or 12 hours.
Utility/System setting.

If the mode is enabled on the Utility > System screen, the Hours box here on the Start
Conditions screen shows the duration of the sample reception mode.
Start Conditions.

For an analysis started with active Sample Reception Mode, the system remains in
operation after the last available sample is processed.

Progression Chart

Pre-operation Operation Standby

Test Rack Test Rack
processing reception processing reception

Rack reception
START RE-START timer setting

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Alarm Setting window

Rack Supply Complete Select this option to enable, or deselect it to disable the rack supply complete alarm.
This alarm (caution level) is issued when all racks reached the output buffer.

Host Communication Setting window

Use this window to define the host computer interface parameters.

For details about host communication settings, refer to the Host Interface Manual for
Roche cobas e 411 analyzer.
There are two options: Elecsys or Cobas protocols.
o Elecsys host protocol - old Elecsys 2010
No “review by exception function” and no support function for Calc tests
(Calc test only on screen and report available).
o Cobas host protocol
Includes “review by exception” function and supports the Calc. test function.

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RS232C Setting area

Speed Transmission speed in bps (bits per second) used for host communication. The
choices are 4800, 9600, or 19200 bps (bits per second).

Frame Use to select the number of data bits used for host communication, parity code, and
the number of stop bits used for host communication for the transfer of a data set.
For data bits, the choice is 7 or 8; for the parity code, the choice is ODD, EVEN, or
NONE. For Stop bits, the choice is 1 Bit or 2 Bits.

Automatic Result Upload Select Yes for results to be uploaded to the host automatically.
If No is selected, no result will be uploaded automatically-irrespective of the Host
Setting on the Start Conditions screen.
Result upload can be initiated manually, for example, after validation.

Communication Trace Select Yes to specify recording the communication between the system and the host.
The recorded communication can be printed out, saved on FD, or deleted through
Print > Utility > Communication Trace (list box). If this check box is clear, the
communication trace is not recorded.

Cobas Type Setting area

Automatic Recovery of Session Select Yes box to specify automatic recovery of session data by the system in case of a
transmission error.

Send Comment Select Yes to specify inclusion of demographic information with test selection
download and result transmission.

QC Additional Information Select which control information is to be uploaded to the host computer. Either the
control name or the control lot number can be selected.

Send Results Only Mode Select Yes to send only results to the host computer. If this check box is selected, the
check boxes in the Results Only area are not available.

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Profile Setting window

Use this window to assign tests to a profile, or to edit or delete an existing profile. Up
to six profiles can be defined.

Profile Name This list contains six positions available for profile name programming, and displays
defined profiles along with the sample type. It is used to select a profile position to be
edited or added.

Available Tests This list displays the names of all tests available on the system. It is used to select tests
to be added to the profile selected in the Profile Name list.

Assigned Tests This list displays the names of all tests assigned to the profile selected in the Profile
Name list. It is used to select tests to be removed from the profile.

Name Setting Choose this button to display the Profile Name Setting window, used to change the
name of a profile (up to 12 characters).

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QC Setting window

Accumulation Method
Use this area to select the type of accumulation (Mean-R or X-R) used by the system.
Selecting Mean-R transfers a mean value, either a weighted mean, according to the
number of points used to calculate the mean, or a non-weighted mean. Selecting X-R
transfers only 1 point. When X-R is selected, the point (1 to 2500) to be accumulated
must be defined on QC > Individual > Accumulate Data.

QC Calculation
Use this area to select the method (Day-to-day or Overall) that the system uses for
calculating the standard deviation for each accumulated control result. Selecting
Overall calculates the SD with all weighted results. Selecting Day-to-day calculates the
SD with all equal results.

Example for QC Calculation:

Individual QC data
Day 1 Day 2 Day 3
20 21 20
19 22 21
19 19 19
20 20 —
— 20 —
n=4 n=5 n=3
mean=19.5 mean=20.4 mean=20.0
SD=0.5 SD=1.0 SD=0.8

QC Calculation (Day to Day) is selected:

+ 20.4 + 20- = 19.96

Accumulated mean = 19.5
--------------------------------------
3

( 19.5 – 19.96 ) 2 + ( 20.4 – 19.96 ) 2 + ( 20.0 – 19.96 ) 2 = 0.45

Accumulated SD = ---------------------------------------------------------------------------------------------------------------------------
3–1

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QC Calculation (Overall) is selected:

Accumulated mean = (--------------------------------------------------------------------------------

19.5 × 4 ) + ( 20.4 × 5 ) + ( 20 × 3 )- = 20.0
12

2 2 2 2
ΣSD ( n – 1 ) = ( 0.5 × 3 ) + ( 1.0 × 4 ) + ( 0.8 × 2 ) = 6.03
2 2 2 2
Σn – mean = ( 4 × 19.5 ) + ( 5 × 20.4 ) + ( 3 × 20.0 ) = 4801.8
2
mean × n = 20 × 12 = 4800

6.03 + 4801.8 + 4800- = 0.84

Accumulated SD = --------------------------------------------------
12 – 1

Range Plot: Select YES to display the range plot in the Cumulative QC Chart window.
If selected, a second graph is displayed on the cumulative QC chart. This plot shows
the range of individual results in each accumulation. The bottom line represents zero,
or no deviation. The center line is 3x the target SD and the top line is 6x the target SD.

See also the Cumulative QC chart section in the Quality control concept chapter.

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Reagent Level Check window

Reagent Level Check

Use to define the level of reagent at which a yellow reagent level alarm is issued. This
level is set for individual tests by number of tests remaining.

User access levels

Access to some screens, especially those of the Utility menu, is confined to the access
level of the user. This section details the access levels of the cobas e 411 analyzer
software screens.
The following sections explain the abbreviations used for access levels and access
rights.

Access levels

o O: Operator (access to routine operation without system setting)

o A: Administrator (system and application configuration and maintenance setting)

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Access rights

o Not accessible
o R: Read only
o E: Edit

Main screens

Menu Screen Button Purpose O A

Workplace Test Selection Register a sample test and check/change a rerun item E E
Comment Enter comment data E E
Previous Jump to the previous test selection E E
Next Jump to the next test selection E E
Save Save a sample test selection E E
Data Review Check a measurement result E E
Comment Enter comment data E E
Search Search for a sample result E E
Filter Filter sample results E E
Send to Host Transmit results to a host system E E
Delete Record Delete individual results E E
Delete All Delete all results E E
Backup Data Save results to a storage device - E
Test Review Check and edit sample results E E
Reagent Reagent Check reagent status E E
Reagent Scan Reagent barcode registration E E
Inventory Set Enter a ProCell lot number E E
Manual Registration Manual registration of a reagent E E
Calibration Status Save, check, and change test calibrations E E
Method Change test calibrations R E
Reject Reject a calibration result E E
Calibration Trace Trace of calibration results E E
Calibration Result List of calibration results R E
Instrument Factor Enter a coefficient for the correction of the difference R E
between instruments
Save Save test calibrations E E
Calibrator Check and add a rack to set a calibrator R E
Position Assignment Add or delete a rack number and position - E
Install Addition and change of tests for each calibrator R E
Scan BC Card Add a calibrator using the barcode card - E
Read Barcode Card Add a calibrator using SmartCOM - E

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Menu Screen Button Purpose O A

QC Status Save, check and change a test for QC E E
Stand By Bottle QC Set QC for a standby reagent pack E E
Select Change a test for QC E E
Save Save QC E E
Run Status Display QC run status E E
Individual Check individual QC data E E
Chart Display an individual QC chart E E
Accumulate Add individual QC data to cumulative data E E
Delete Partial rejection of individual QC data - E
Cumulative Check of cumulative data E E
Chart Display a cumulative QC chart E E
Delete Delete cumulative data - E
Control Check and add a rack to set control R E
Position Assignment Add and delete a rack number and position E E
Install Add and change a test for a QC sample R E
Add Add a new QC sample - E
Delete Delete QC sample - E
Scan BC Card Add QC sample using a barcode card - E
Download Add QC sample using SmartCom - E
Edit Save concentrations for a test - E
Activate/Inactivate Test Select a test for a QC sample - E
Utility System Configure an instrument R E
Set date and time E E
Host Comm. Setting Configure host communication parameters - E
Profile Setting Set profile test groups - E
QC Setting Set QC method - E
Reagent Level Check Set reagent check levels - E
Operator ID Assign operator IDs - E
Check Digit Set a sample ID barcode check method - E
Documentation Setup Set a printout mode - E
Review By Exception Exclude selected data from transmission to SmartCom - E
Download Setting Set the download location for parameters - E
Storage Utility Data backup and restore - E
Special Function Serial No., Install Date - E
Effective signal output - E
Keep Function Set the keep function - E
Retry function Set the retry function - E
Maintenance Perform maintenance actions E E
Maintenance Perform operator maintenance actions E E
Check Perform mechanical checks - E
Service Perform service functions - E

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Menu Screen Button Purpose O A

Application Register application parameters R E
Analyze Register analysis parameters R E
Calib. Register calibration parameters R E
Range Register range parameters R E
Calc. test Program calculated tests R E
System Overview Indicate the status of analyzer E E
Maintenance Jump to the Maintenance screen E E
Sample Data Clear Delete all sample data E E
Reagent Load List Print a reagent load list E E
Calib/QC Load List Print a calibration/QC load list E E
Parameter Download Calibrator/QC samples download via SmartCOM E E
Sample Tracking Check sample status E E
Print View Display the printout results on the monitor E E
Temperature Display the analyzer temperature E E
Alarm Jump to the Alarm screen E E
Reagent Scan Reagent barcode registration E E
Work Place Jump to the Workplace screen E E
Reagent Jump to the Reagent screen E E
Calibration Jump to the Calibration screen E E
Utility Jump to the Utility screen E E
Sample Tracking Check sample status E E
Current Disk Return to the current disk E E
Show Result Check sample results E E
Search Search for a sample result E E
Search Next Search for the next sample result E E
Sample Scan Sample barcode registration E E
Status Report Print a sample status list E E
Global Stop Request an operation stop E E
Logoff User logoff/system shutdown E E
S.Stop Request a sample stop E E
STAT Rack Measuring the STAT mode rack E E
Alarm Review the alarm list and remedies E E
Delete Delete an alarm E E
New Alarm Update the alarm list E E
Maintenance Jump to the Maintenance screen E E

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Menu Screen Button Purpose O A

Sound On/Off Set the alarm buzzer to On or Off E E
Print Workplace Print routine measurement data E E
Reagent Print reagent data E E
Calibration Print calibration data E E
QC Print QC data E E
Utility Print utility data E E
View Display the printout results on the monitor E E
Refresh Refresh the View screen E E
Jump Jump to a print a page of data E E
Print Print View screen data E E
Delete Delete View screen data E E

Global screens

Screen Button Purpose O A

Start Enter analysis start conditions E E
Masking Mask test per channel E E
Default Profile Define default profiles - E
Print Print reports for each menu E E
Work Place Print routine measurement data E E
Reagent Print reagent data E E
Calibration Print calibration data E E
QC Print QC data E E
Utility Print utility data E E
View Display reports on the monitor E E
System Overview Indicate the status of the analyzer E E
Alarm Jump to the Alarm screen E E
Reagent Overview Indicate the status of reagents and inventory E E
Cancel Maintenance Cancel the maintenance function E E
Daily Maintenance Jump to the Maintenance screen E E
Sample Data Clear Delete all sample data E E
Reagent Load List Print a reagent load list E E
Calibration/QC Load List Print a calibration and QC load list E E
Sample Tracking Check sample status E E
Alarm Review the alarm list and remedies E E
Delete Delete an alarm E E
New Alarm Update the alarm list E E
Sound Adjust the buzzer sound E E
Maintenance Jump to the Maintenance screen E E
S. Stop Request a sample stop E E
Stop Request an operation stop E E

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Operator ID window

At least one administrator level log-on ID must remain in the system at all times. Use
this window to assign user IDs and security levels.
After an operator ID is established, the password entered the first time the operator
ID is used becomes the permanent password for this operator ID.
If a password for an existing operator has been lost, the ID must be deleted and
reprogrammed.

This list displays IDs with their security levels currently defined on the system. Levels
include Administrator, Supervisor, and Operator (draft version) and allow the user
different access rights to screens, windows, boxes, and functions in the software. Up to
40 IDs can be defined.

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The Password Protection Setting window is used to switch password protection on or

off.

If the system is in password protection mode, each user must enter a password at the
login screen. If the system is not in password protection mode, no password is
required, but it is still necessary to enter a user ID as user access level control remains
in operation.
The Service user ID is always password-protected, regardless of whether password is
enabled or not.

Documentation Settings window

Used to enable or disable automatic printing of quality control results, emergency

(STAT) samples, the calibration result, and the routine sample.

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Completion Conditions area

Printout Select this option to send reports to the printer only.

Upload Select this option to upload reports to the host only.

Print/Upload Select this option to send reports to the printer and also upload reports to the host.

Printer Connection area

Connected Select this option if a printer is connected to the system and reports are required.

Not connected Select this option if reports are not required (whether or not a printer is connected to
the system). If the print button is chosen for a printing list, the information is
displayed on the print view only, even though the Not Documented option is chosen.

Automatic Printout area

Setting can be done for: Calibrations, Controls, STAT, and Routine Samples.
When any of these automatic printout options is selected, the system prints the results
from every sample of that type without any further operator action.

Review By Exception window

Used to select which data alarm, if present, prevents a test result from being sent to
the host computer.

All data alarms, which are listed in the Troubleshooting chapter, are displayed under
the Alarm column, and can be assigned to the Exception Alarm column.

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Check Digit window (barcode mode)

This is used to enable or disable barcode check digits, which are used to verify that the
barcode on the sample tubes has been read correctly. Any combination of the three
barcode checks can be selected.

Download Setting window

Used to select the source of test parameters (for example, sample IDs and test
selections) used by the cobas e 411 analyzer.

DVD Select this option to obtain test parameters from the DVD.

Smart COM Select this option to obtain test parameters from cobas Link.

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Storage Utility window

Use this window to retrieve stored data from the selected storage device.

Read area

Read System Specific Data Under investigation

Read Reference Data For example, Assay protocol data for tests and diluents (Name, Test No, Unit,
Expected ranges)

Read Mecha Adjustment Data For Service action only.

Read Rack Adjustment Data For Service action only.

Backup area
Select this option to create a backup or a restore of data to the selected storage device.
This utility saves the calibration, control and sample results, system status (details of
reagents on board) and consumables data). The Backup Data window saves the test
review information.

Target Device area

Internal Select this option to choose to read and write to internal memory.

External Select this option to choose to read and write to an external memory device.

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Special Function window

Use this window to view and define system information and parameters, which is a
part of system installation (done by service technicians)

For Software support and troubleshooting purposes, Serial number and Software
number is important to mention in a Clarify case.
Effective Signal Output could be chose to switch on. The signals will be displayed
under the Workplace/Data Review/Test selection and printed on the report.

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Keep Function Setup window

Use this window to select the default for sample type and sample cup.

Keep Sample Type Select this option to keep the previously selected sample type (normal or reduced) for
patient samples without having to make a renewed selection.

Default Sample Cup Select this option to use, for example, reduced sample cup as a default for all
measurements. This means the minimum sample volume for samples of the normal
Hitachi cups is reduced.

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Retry Function Setup window

Use this window to request additional sample pipetting procedures, if special alarms
were issued during the first sample pipetting. Be aware, that this setting could reduce
the sample throughput.

When Sample Premature LLD When this option is set to ON and if the “Sample LLD noise before and after
aspiration” alarm occurs, the system repeats the pipetting procedure, twice at most,
from the same sample cup (no change to sample cup reduced).

When Sample Short When this option is set to ON and if one of the following alarms occur:, “Sample
short (no LLD before Z-max)” or “Sample short (before aspiration)”, the system
repeats the pipetting procedure, only once, in the mode “other” from the same
sample cup.
For Sample short, this function works only when the mode is sample cup normal. If
an LLD is detected, but not within the correct parameters, the instrument changes to
mode sample cup reduced and performs a second sample pipetting procedure.

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Application

Application

The Application screen is used to view, add and updates application parameters.
The Application menu consist of three tabs: Analyze, Calib, and Range.

Analyze screen

Test list This list displays all tests scanned on the system. A maximum of 18 test positions can
be displayed.

Sample Volume Displays the volume of sample required for the selected application.

Default Diluent Ratio Displays the required dilution ratio for a test.
As a default, a 1:1 dilution is entered for all the measurements. If all samples should be
diluted for a test, for example 1:100, than the ratio should be changed accordingly.

Dilution Ratio Possibilities 1:1, 1:2, 1:5, 1:10, 1:20, 1:50, 1:100.

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Application

Calib. screen

Use this screen to display analysis parameters and to change calibration causes to QC
Violation.

Daily Calibration Choose On to instruct the system to run a calibration each day.

Duplicate Limit % The default value 10% has to be changed to 20%, for the following tests: T-UP, A-
HBCIGM.

QC Violation When On is selected, the settings in the QC Violation Setting area are available.

QC Violation Setting area Used to set a confidence range and to preselect the calibration method to be
recommended in case of a QC violation through the specified controls.

Rule The options are used to set the QC confidence range for 1SD or 2SD or 3SD range.
Setting of 1 of the rule is only possible if the control card is scanned. Calibration will
be initiated if the QC results are outside the confidence limit. For each application,
you have to define the calibration method, the confidence limit (Rule), and up to 3
different controls.
It is recommended to decide for one calibration workflow - timer-triggered or QC-
triggered for all applications. Only a few specific applications require the timer
triggered.
Based on the chosen rule, the confidence limit is calculated according to following
formula:
Confidence interval High/Low= QC target mean +/-(Target SD * selected rule)

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cobas e 411 analyzer 16 Utility menu
Application

Range screen

Used to display the test number, user test number, unit, and expected values for each
test.

Test No. Displays the reference test number for the selected test.

User Test No. Used to apply a custom user test number to the selected test. By default, this box
displays the reference test number. This is an important setting for Host
communication and system settings.

Unit Used to select the unit of measure for the selected test. Up to 3 or 4 units can be
chosen according to the test application.

Expected Values area Used to define the normal expected value ranges for the three sample material types.
Select the option for each sample type to specify the normal expected value ranges in
the adjacent text boxes.
If the result for this test falls outside the range entered here, the system issues a data
alarm.

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Application

Calculated Test screen

A calculated test result is not actually performed on the system, but is calculated from
other test results that have been run on the system.

Calculated Test list Five possible positions for the test calculation are available in the Calculated Test list.
If calculated tests have been programmed already, they are displayed in the Calculated
Test list.
Calculated Test results can only be sent to the host if the cobas e 411 protocol type is
used and the host system is able to upload it.
The following calculated test formulas are available and can be entered:

% free PSA ratio = free PSA * 100/total PSA

fT4 index = T4/TBI
% FTI (free testosterone index) = Testosterone * 100/SHBG

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Exercise 7: Start up and routine operation

Laboratory exercises

Exercise 7: Start up and routine operation

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Perform correct start-up procedures
o Demonstrate proper reagent handling
o View messages, colors, and alarms before and during the run
o Print the reagent load list
o Delete open requisition

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Exercise 7: Start up and routine operation

Exercises

o Switch on the printer, system and control unit.

Check that:
Perform correct start-up o The indicator lights are on
procedures o There is sufficient paper in the printer
o Probes, pipetting station and incubator are clean
o Pipetters are bubble free
o Type the operator ID in the Operator ID text box.
o Type the password in the Password Text box.
o Touch log on
Log on with your Operator
o The operator ID is displayed in the status line
ID name
o Check the inventory for all of the reagents are on board,
and troubleshoot any events that are displayed.

Demonstrate proper reagent Check the following:

handling and o System reagents: ProCell, CleanCell and open the lid
check the graphical inventory o Fill system water (3 L distilled water + 35 mL SysWash)
or reagent list o Empty liquid waste container and solid waste tray
o Check tips and cups
o Touch the global button Alarm button and check the
systems instrument for any alarms.
o Touch the Alarm button from the graphical inventory.
View messages, colors, and
o Check the temperature under the graphical inventory.
alarms during the run in case
of trouble
o Touch the Reagent Load List button from the System
Overview or touch global button Print/Reagent tab.
o Print the reagent load list and check the information.
Print the reagent load list
o Touch the Print View button from the System Overview.
o Before beginning, check whether data should be backed
up first.
o Check if measured patients are documented (send to
Delete open requisitions
host)
o Touch the Sample Data Clear button from System
Overview or Workplace/Data Review button and press
delete All

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Exercise 8: Start up and routine operation

Exercise 8: Start up and routine operation

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Program routine (primary tubes with barcode labels)
o Program routine (cups without barcode labels and use the reduced type)
o Deal with auto diluents for a test
o Printing the work list and inventory list and use the print view as well
o Track sample progress through the run

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Exercise 8: Start up and routine operation

Exercises

Use different fields for running five samples:

o STAT and routine tab
Program routine o Sample type serum
(primary tubes with barcode o Sample ID number from the barcode label
labels) o Sample volume (dilution factor) for a test

Deal with auto diluents for a

test
Use different fields for running two samples:
o Routine tab
Program routine (cups o Sample type urine
without barcode labels) o Patient name

o For disk systems, use the Disk ID (non-barcode mode)

o For rack systems, use the Rack ID (non-barcode mode)

o Use “reduced minimum sample volume”
o Touch the global Print button and select the work list and
inventory list to print the data
o Check the lists and troubleshoot if necessary
Printing the work list and
inventory list and use the
print view as well
o Touch Sample Tracking button from System Overview
o Check the sample status
Track sample progress
through the run

o For disk system results for each sample in positions 1 to

30 on the sample disk (multiple or single disk use)

o For rack system results for each sample in the output

buffer contains five racks, each containing five sample
positions

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Exercise 9: Start up and routine operation

Exercise 9: Start up and routine operation

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Review results relating to system alarms and data flags
o Print result report

Exercises

View the results from different screens for evaluation:

o Sample tracking screen
Review results relating to o Alarm screen, leave alarm messages until result
system alarms and data flags evaluation is finished completely
o Workplace/Data Review screen
o Workplace/Data Review/Test Review screen
o Workplace/Data Filter function
If a flag appears, troubleshoot the corresponding condition
using the Training Guide/Troubleshooting/Data Alarms
and Help function from the user interface.

o Print the Result Report-normal format

o Result Report-condensed format
o Use Print View button as well from the System Overview
Print result report

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17 Laboratory exercises cobas e 411 analyzer
Exercise 9: Start up and routine operation

Quiz

Mark each of the following statements with a l if true for startup and routine
operation:

Switch on the cobas e 411 analyzer with the main circuit breaker

To log on with an operator ID, access level has to be defined with a minimum of one
access level for a operator ID.
ProCell and CleanCell bottle lids have to be closed before starting.

This icon means that the reagent in the graphical inventory has expired.

Sample mix mode (samples with and without BC labels) is not allow during a run.

>Ref/<Ref flags are belonging to control flags only.

Sample signals can viewed on the Test Review screen and on the Result Report.

An AM status Flag is visible in Test Review if an abnormality appears during

processing. This means that the test is still ordered but the reagent pack is not on
board or is empty. Therefore the test could not be performed.

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Exercise 10: Adding new tests to the system

Exercise 10: Adding new tests to the system

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Program the cobas e 411 analyzer for a new test

Exercises

Register the new reagent on the system

o Load the new reagent pack and open the reagent lids
slightly.
o Perform a REAGENT SCAN from the Reagent menu or
System Overview screen.
Scan the barcode card for the calibrators of the new test.
o Place the card into the reading position correctly.
o Touch Calibrator/Install/BC Card Scan.
o Do not remove the card until the status line displays
Standby mode.
Activate the test to the relevant control.
o If the control card for that particular test is already
installed, activation of the test is essential.
o Touch Control/Install and activate the new test for the
specific controls and press save.
Configure the test application settings.
o Touch Utility/Application.
o Select the new test verify the test settings.
o Go to Utility/Application/Analyze and check if the default
diluent ratio or if an other diluent factor should be used
for the first result measurement.
o Use the TG/Reagent Concept chapter/Universal Diluent
or MultiAssay (MA) recommendation list.
o Go to Utility/Application/Calib. and change the settings
of Daily Calibration and Duplicate Limit % if necessary.
o Decide the calibration workflow options whether
Timeout or QC Violation is used for the trigger of the
calibration cause.
O If Timeout is preferred, choose OFF for QC Violation.
O If QC violation is preferred, choose ON for QC
Violation.
o Decide the QC Violation rule settings: 1, 2, or 3 SD range
can only be done if the control barcode card is scanned
before.

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Exercise 11: Adding new tests to the system

Exercise 11: Adding new tests to the system

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Program the cobas e 411 analyzer for a new test
o Program a calculated test formula of the new test, if necessary
o Verify that all new settings are programmed properly by calibrating and
controlling the new test

Exercises

Configure the test application settings

o Touch Utility/Application/Range.
Program the cobas e 411 o Verify the User Test number according to Host settings.
analyzer for a new test o Choose the proper Unit from the field box
o Define the normal expected value ranges for the three
sample material type, if necessary.
o Save all the application changes of the new test.
Configure the calc. test formula
o Go to Utility/Calc. menu.
Program a calculated test o The following formulas are available and can be entered:
formula of the new test, free PSA
if necessary % free PSA ratio = ----------------------- × 100
total PSA
T4-
fT4 index = --------
TB1
Testosterone
% FTI (free testosterone index) = -------------------------------- × 100
SHBSG
Perform calibration and quality control testing
o Load new calibrator vials first and then new control vials.
Verify that all new settings o Pour control material for non-Roche control into a
are programmed properly by normal Hitachi sample cup and program a rack
calibrating and controlling assignment for this control.
the new test Perform sample processing
o Program five samples for the new test.
o Load the patient samples.
o Make sure that no alarm is displayed before starting the
run.
o Press Start.
Perform result evaluation
o Evaluate calibration, control and samples results of the
new test.

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cobas e 411 analyzer 17 Laboratory exercises
Exercise 11: Adding new tests to the system

Quiz

Mark each of the following statements with a l if true for startup and routine
operation:

The Application screen is used to view, added and updates application parameters.

The Default ratio field settings is in charge of the second measurement of a rerun.

Both calibration workflow options “Timeout and QC Violation” can be used for a
test.
Units can be changed only once after installation of the new test.

User Test Number is important for Host and Key settings.

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Exercise 12: Calibration and quality control

Exercise 12: Calibration and quality control

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Prepare calibrator and quality control materials according to packages inserts
o Perform a bar-coded calibration run

Exercises

CalSet components
o Separate calibrators are required for each tests.
Prepare calibrator and quality o Two sets/levels of calibrators are packaged in each kit.
control materials according to o Check the stability and storage information.
packages inserts o Bring the calibrator material to room temperature before
testing.
Control Set components
o Different controls belonging to several tests.
o Usually, two set/Levels of controls are packaged in each
kit.
o Check the stability and storage information.
o Bring the control material to room temperature before
testing.
o Scan process can be done in Standby mode only.
o Place the calibrator bar-code card after installation and
settings of the applications.
Perform a bar-coded
o Certain tests, e.g. HBsAG, Anti-TPO come with
calibration run
calibrators in the reagent kit, therefore no bar-code card
is required.
o Touch the Calibrator/Install menu and select the Scan BC
card tab.
o Do not remove the card until the system returns to
Standby.
o Repeat it for all tests and if with new lots.
o Check if all the calibrators are install correctly
(highlighted with blue color).
o Load the calibrators, with lids open, observing correct
placement of vials.
o Both calibrator vials must be next to each other.
o Do not split a calibrator set between two racks.

o On the disk system, place the Stop barcode tube after the
last vial.

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Exercise 13: Calibration and quality control

Exercise 13: Calibration and quality control

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Perform a bar-coded control run
o Request and print the calibration and control list

Exercises

o Scan process can be done in Standby mode only.

o Place the control barcode card after installation and
settings of the applications.
Perform a bar-coded control
o Touch the Control/Install menu and select the Scan BC
run
card tab.
o Do not remove the card until the system returns to
Standby.
o Repeat for all control materials and if a new lots is
available.
o Check that all the controls are installed correctly.
o Activate the test applicable to the controls.
o If a non-Roche control is used, select Add button and
enter the information, target values, and standard
deviations for the applicable tests. If done afterwards,
choose Edit, then active the tests as well.
Because no bar-code labels are available for non-Roche
controls, rack assignment has to be done.
o Load the controls, with lids open, observing correct
placement of vials.
o Controls can be placed separately.
o

o On the disk system, place the Stop barcode tube after the
last vial.
Calibration:
o Touch the Calibration/Status menu and select the test
Request and print the which should be calibrated or a calibration cause is
calibration and control list displayed and is required to calibrate.
use the print view as well Control:
o Touch the Control/Status menu and select the tests which
has to be controlled.
Print the list:
o Touch Global Button Print button and select the load list
for calibrator and controls.
o Check the lists and troubleshoot if necessary.
If vials are prepared and on board, press Start to initiate the
run.

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Exercise 14: Calibration and quality control

Exercise 14: Calibration and quality control

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Evaluate control results

Exercises

o Touch Sample Tracking button from System Overview

o Check the status of the calibration and control vials
Track sample progress o
through the run

o For disk systems, check results for each sample in

positions 1 to 30 on the sample disk (multiple or single
disk use).

o For rack systems, check for each sample in the output

buffer contains five racks, each containing five sample
positions.
View the calibration results from different screens:
o Sample tracking screen
Evaluate calibration results o Alarm screen, leave alarm messages until result
evaluation is finished completely
o Calibration/Status/Calibration Result menu
o Calibration/Status/Calibration Trace menu
o If a calibration has failed, troubleshoot the problem and
repeat it to the corresponding condition using the
Training Guide/Calibration menu/Calibration Quality
Criteria and Help function from the user interface
o Usually, calibration result is printed automatically after
measurement.
o Usually, calibration result is printed automatically after
Print calibration result and
measurement.
trace list
o Use the Print button, if printing has to be started
manually.
o Print a calibration trace list as well.
o Also use Print View button on the System Overview
screen.

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Exercise 15: Calibration and quality control

Exercise 15: Calibration and quality control

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Evaluate control results

Exercises

View the control results from different screens:

o Sample tracking screen
Evaluate control results o Alarm screen, leave alarm messages until control result
evaluation is finished completely
o Workplace/Data Review screen
o Workplace/Data Review/Test Review screen
o Workplace/Data Filter function for controls
o Control/Run Status
o Control Individual screen and chart
o If a control gets a flag, troubleshoot the problem and
repeat it to the corresponding condition using the
Training Guide/Control menu and HELP function from
the User Interface
o Usually, calibration result is printed automatically after
measurement.
o Usually, control result is printed automatically after
Print control result and
measurement.
individual control chart and
o Use the Print button, if printing has to be started
list
manually.
o First select the controls from the Workplace/Data Review
which should be printed.
o Print individual control chart and list too.
o Use Print View button as well from the System Overview.

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Exercise 15: Calibration and quality control

Quiz

Mark each of the following statements with a l if true for calibration and quality
control:

Only one calibration lot number can be installed for a test.

If the Expiration column is highlighted in red, the corresponding calibrator has

expired and can not be used anymore.
If the difference between the duplicate measurements of one or more calibrator level
is too high (in general > 10%), the calibration is failed (yellow).
Run Status screen is used to get an overview of the last 500 quality control (QC)
measurements or to view the most recent QC measurements for one particular test
specified.
Individual QC Chart screen displays all recent values per test for each control.

This icon is used for standby controls, which can be viewed under the QC
chart.

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Exercise 16: Addition routine tasks

Exercise 16: Addition routine tasks

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Add routine samples during run
o Add STAT samples during run
o Program a sample with an manual rerun

Exercises

Use different fields for running two samples, when the system
has started sampling:

Add routine samples during o Add two routine samples

run o Sample type serum
o Sample ID number from the barcode label
o Sample volume (dilution factor) for a test
Use different fields for running two samples:
o Press STAT rack/STAT disk button for a STAT samples
Add STAT samples during o Use STAT tab for the identification
run o Sample type serum
o Patient name
o

o For disk systems, use the Disk ID (non-barcode mode).

o For rack systems, use the Rack ID (non-barcode mode).

o Use normal sample volume.
o If system is in S.Stop, press Start again.
o Follow the status from the sample tracking screen.
o Precondition:
>Ref flag is displayed for a sample ID
o Select the sample ID from the Sample Tracking screen or
Program a sample with an
from the Data Review screen.
manual rerun
o Same sample ID is used and marked with the tab rerun.
o Test is added and started once again.
o Before starting, make sure that diluent for that particular
test is on board.

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Exercise 17: Addition routine tasks

Exercise 17: Addition routine tasks

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Prepare control material according to package inserts
o Control all the active and standby reagent packs with are on board

Exercises

o Kits may contain one, two, or three levels of quality

controls material.
o Usually, two sets of controls are packaged in each kit.
Prepare control material
o Control target values and ranges are read into the system
according to package inserts
with the control card.
Use two control levels with barcode labels:
o Go to the Control/Status screen.
o Select the routine tests to be controlled.
o Go to the Control/Status/Standby screen.
o Select the standby tests to be controlled.
o Print the control load list from the System Overview or
from the Print button.
o Check the required volume.
o

o Place the vials into a disk.

o Or place the vials into a rack.

o Press Start.
o Follow the status from the sample tracking screen.
View the control results from different screens for evaluation:
o Sample tracking screen
Review results relating to o Alarm screen, leave alarm messages until result
system alarms and data flags evaluation is finished completely
o Workplace/Data Review screen
o Workplace/Data Review/Test Review screen
o Workplace/Data Filter function
If a flag appears, troubleshoot the corresponding condition
using the Training Guide/Troubleshooting/Data Alarms and
HELP function from the User Interface.

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Exercise 17: Addition routine tasks

Quiz

Mark each of the following statements with a l if true for additional routine tasks:

Controls are used to monitor system accuracy and reproducibility over time.

Control Load list can be printed from the System Overview only.

Standby reagent packs can be viewed on the graphical System Overview screen,
Reagent list, Control/Status/Standby QC bottle screen and on printing lists, Test
Review screen.
Controls do not get the status P (in processing) in the sample tracking screen.

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Exercise 17: Addition routine tasks

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18 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-99
cobas e 411 analyzer 18 Troubleshooting
Introduction

Troubleshooting

Introduction

If any abnormality occurs while the system is switched on, the system notifies the
operator of the potential problem by issuing an alarm. These alarms comprise data
alarms (referring to irregular measuring results or conditions) and instrument alarms
(referring to irregular system conditions).

Alarm levels Alarms are classified into various levels:

Data alarm Data alarms are indicated on the Workplace > Data Review screen, on the
Test Review screen, and on printed reports.
If a data alarm occurs, the analyzer does not stop operation. A flag is
attached to the measurement result of patient or control samples.
Warning This alarm is generated by data alarms or problems with the system. If
this alarm occurs during operation, the analyzer does not stop operation.
The operator must judge whether to continue or interrupt measurement.
Sampling stop This alarm concerns troubles on the instrument. For the pipetted sample
measurement is continued.
Stop This alarm concerns troubles on the instrument. The system stops
operation within one cycle (6 seconds). For the sample under
measurement, no result data are obtained and the measurement must be
repeated.
Emergency stop This alarm concerns troubles on the instrument. The system immediately
stops operation. For the sample under measurement, no result data are
obtained and the measurement must be repeated.
Instrument These alarms are indicated by the Alarm button on the software overview
alarms screen as well as by an audible alarm. If an alarm occurs, the Alarm
button lights up. The color indicates the alarm level:
o Yellow indicates warning level
o Red indicates emergency stop

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List of data alarms

List of data alarms

The following table displays the data alarms and their presentation (flag) on screens
and reports.

Flag (screen) Alarm (report)

>AB AB level range over
>Curr Measuring cell current range over
<SigL Low level signal
>Test Measurement range (upper)
<Test Measurement range (lower)
AB.E AB level check error
ADC.E ADC abnormal
Cal.E Calibration result abnormal
Calc.? Calculation not possible
Cancel Power Fail/Power Off Cancel
Cancel E.STOP Cancel
Cancel STOP Cancel
Cancel P.STOP/A.STOP Cancel
Cancel S.STOP Cancel
Cancel Recovery Cancel
Cancel Sample ID Error Cancel
CarOvr Potential microparticle carry over
ClcT.E Calc Test Error
Cell.T Cell temperature
Curr.E Measuring cell current check
FacA Instrument factor A reset
H Outside of expected value (upper)
Inc.T Incubator temperature
L Outside of expected value (lower)
Over.E Overflow
ReagEx Reagent expired
Reag.F Assay reagent film detected; Diluent film detected; Pretreatment film
detected
Reag.H Assay reagent hovering; Diluent hovering; Pretreatment hovering
Reag.S Assay reagent short; Diluent short; Pretreatment reagent short
Reag.T Abnormal reagent disk temperature
Samp.C Sample clot
Samp.S Sample short
SLLD.E Sample LLD abnormal
SLLD.N Sample LLD noise
SysR.S System reagent short
SysR.T System reagent temperature
SysR.U System reagent temperature unstable

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Data alarms: general

Data alarms: general

>AB

Alarm AB level range over

Description During run preparation, the ProCell count level was out of range (the ProCell signal
was <200 or >400 counts).

Cause The ProCell has evaporated or may be contaminated.

Remedy 1 Check for bubbles in the ProCell bottle.

2 Try a new bottle of ProCell.
3 Rerun all flagged samples.
4 If the error recurs, call Technical Support.

>Curr

Alarm Measuring cell current range over

Description The measuring cell current was out of range when checked during run preparation.

Cause Abnormal measuring cell condition.

Remedy 1 Choose Utility > Maintenance > Maintenance and perform the Liquid Flow
Cleaning maintenance item (10 cycles).
2 Rerun all flagged samples.
3 If the alarm recurs, call Technical Support.

<SigL

Alarm Low level signal

Description The signal is lower than the specified lower limit value coded in the reagent pack
barcode. For qualitative and quantitative assays.

Cause o The ProCell has expired.

o The standard solution does not reach room temperature.
o The volume of the reaction mixture in the AssayCup is insufficient.
o Abnormal measuring cell condition.

Remedy 1 Replace ProCell.

2 Rerun the sample.
3 If the alarm persist, call Technical Support.

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Data alarms: general

>Test

Alarm Measurement range (upper)

Description The measured value is above the upper limit of the measuring range encoded on the
reagent pack barcode.

Cause The sample concentration is above the upper limit of the measuring (reportable)
range.

Remedy Rerun using the recommended dilution and check the measured value.

<Test

Alarm Measurement range (lower)

Description The measured value is below the lower limit of the measuring range encoded on the
reagent rack barcode.

Cause The sample concentration is below the lower limit of the measuring (reportable)
range.

Remedy Report the result as less than the lower detection limit of the assay. Rerun is not
requested.

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Data alarms: general

AB.E

Alarm AB level check error

Description The ProCell level check failed.

Cause ProCell liquid level check failed. The ProCell Volume is inadequate for run
preparation.

Remedy 1 Replace the low volume ProCell bottle with a new bottle.
2 Rerun all flagged samples.
3 If the alarm recurs, call Technical Support.

ADC.E

Alarm ADC abnormal

Description The analog-digital converter data is abnormal.

Cause o Numerical conversion is abnormal.

o The cell count is abnormal.

Remedy 1 If other instrument alarms exist, correct those alarms and resume operation.
2 Choose Utility > Maintenance > Maintenance and perform the System Reset
maintenance item.
3 If the alarm recurs call Technical Support.

Cal.E

Alarm Calibration result abnormal

Description There is no valid calibration data in the system for this reagent pack (that is, a new
assay on the analyzer).

Cal.E appears on each control and patient sample for the affected test until the problem is resolved.

Cause o There is no valid calibration stored in the system.

o The attempted calibration is questionable or failed.

Remedy 1 Check the calibrators and reagents and repeat the calibration.
2 Set new calibrators and a reagent pack if necessary, and repeat the calibration.
3 Rerun the samples after a successful calibration is obtained.

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Data alarms: general

Calc.?

Alarm Calculation not possible

Description The denominator becomes zero in calculation.

Cause Internal calculation error occurred.

Remedy Rerun the sample.

Cancel [Power Fail/Power Off Cancel]

Alarm Power failure - operation stopped.

Description The test concerned was cancelled by power fail or power off.

Cause Test cancelled due to power failure or power off. Sample(s) may be excluded; refer to
printout.

Remedy Correct condition and rerun any excluded samples.

Cancel [E.STOP Cancel]

Alarm E.STOP - operation stopped.

Description The test concerned was cancelled by E.Stop.

Cause Test cancelled due to E.Stop. Sample(s) may be excluded; refer to printout.

Remedy Correct alarm condition and rerun any excluded samples.

Cancel [STOP Cancel]

Alarm Stop - operation stopped by operator.

Description Operation stopped by operator or the test concerned was cancelled by Stop.

Cause Operation stopped by operator. Sample(s) may be excluded; refer to printout.

Remedy Correct alarm condition and rerun any excluded samples.

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Data alarms: general

Cancel [P.STOP/A.STOP Cancel]

Alarm P.STOP/A.STOP - operation stopped.

Description The test concerned was cancelled by P.Stop.

Cause Test cancelled due to P.Stop or A.Stop. Sample(s) may be excluded; refer to printout.

Remedy Correct alarm condition and rerun any excluded samples.

Cancel [S.STOP Cancel]

Alarm S.STOP - operation stopped.

Description Operation stopped by operator or the test concerned was cancelled by S.Stop.

Cause Sampling stopped due to S.Stop. Sample(s) in process will be completed.

Remedy Correct alarm condition and continue with samples to be processed.

Cancel [Recovery Cancel]

Alarm Instrument handling error - determination not performed.

Description Determination not performed.

Cause Test cancelled due to instrument handling error. Sample(s) may be excluded; refer to
printout.

Remedy Rerun any excluded samples.

Cancel [Sample ID Error Cancel]

Alarm Sample ID Error Cancel.

Description Sample ID scanning was not successful.

Cause The sample ID that was scanned just before pipetting is different from the ID scanned
during the sample scan. All tests for the sample were cancelled.

Remedy Verify that sample tubes are not removed until the Status screen reads “Proc” or
“Complete”.

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Data alarms: general

CarOvr

Alarm Potential microparticle carry over

Description The signal level of this sample is low.

Cause Carryover from the previous sample may have occurred.

Remedy Rerun the sample.

ClcT.E

Alarm Calc Test Error.

Description Data flag is attached. If one or both of two tests are flagged, no result.

Cause A data alarm has occurred for a test needed in the calculation. It is not valid for the
alarm “Calculation not possible” (Calc.?).

Remedy Repeat BlankCell calibration.

Cell.T

Alarm Abnormal measuring cell temperature

Description Measuring cell temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.

Cause o Radiation of heat does not work normally.

o The room temperature is out of range.

Remedy 1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18°C and 32°C.
3 If the alarm recurs, call Technical Support.

Curr.E

Alarm Measuring cell current check

Description The measuring cell current check failed.

Cause ProCell liquid level check failed. The ProCell volume is inadequate for run
preparation.

Remedy 1 Replace the low volume bottle with a new bottle.

2 Rerun all flagged samples.
3 If the error recurs, call Technical Support.

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Data alarms: general

FacA

Alarm Instrument factor A reset

Description The instrument factor A was set to 1.0 by the system.

Cause For information only.

Remedy Repeat BlankCell calibration.

Alarm Outside of expected value (upper)

Description For patient samples, the calculated concentration is greater than the upper limit of the
expected value range.
For control samples, a concentration exceeded the 3 SD values specified on QC >
Install.

Cause o The sample concentration is higher than the expected value.

o A proper expected value range is not specified.

Remedy 1 Follow laboratory protocol for high samples.

2 Specify a proper range under Expected Values in Utility > Application > Range.

This alarm DOES NOT cause an incomplete sample status alarm.

Inc.T

Alarm Incubator temperature

Description Incubator temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.

Cause o Radiation of heat does not work normally.

o The room temperature is out of range

Remedy 1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18°C and 32°C.
3 If the error recurs, call Technical Support.

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Data alarms: general

Alarm Outside of expected value (lower)

Description For patient samples, the calculated concentration is less than the lower limit of the
expected value range.
For control samples, a concentration was less than the 3 SD values entered on QC >
Install.

Cause o The sample concentration is lower than the expected value.

o A proper expected value range is not specified.

Remedy 1 Follow laboratory protocol for low samples.

2 Specify a proper range under Expected Values in Utility > Application > Range.

This alarm DOES NOT cause an incomplete sample status alarm.

Over.E

Alarm Overflow

Description The result is mathematically overflowed.

Cause Wrong calibrator. The data contains more than six digits (including a negative sign
and decimal point).

Remedy Minimize the difference in concentration between the sample and the calibrator.

ReagEx

Alarm Reagent expired

Description An expired reagent was used for the measurement.

Cause For information only.

Remedy Not applicable

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Data alarms: general

Reag.F

Alarm Assay reagent film detected; Diluent film detected; Pretreatment film detected

Description Foam or film was detected above reagent.

Cause o Foam or film was detected above reagent.

o Foam or film was detected above diluent.
o Foam or film was detected above pretreatment reagent.
o Foam or film was detected above ProCell or CleanCell.

Remedy Remove foam or air bubbles with an applicator stick and rerun the affected sample.

Reag.H

Alarm Assay reagent hovering; Diluent hovering; Pretreatment hovering

Description The reagent probe hovers over the reagent rotor.

Cause A premature LLD signal was detected during reagent pipetting, causing the S/R probe
to hover over the reagent pack.

Remedy 1 Dry the lids on the affected reagent pack.

2 Check for bubbles in the affected reagent pack. If bubbles are present, remove with
an applicator stick.
3 Choose Utility > Maintenance > Maintenance and perform the System Reset
maintenance item.
4 If the error recurs, call Technical Support.

Reag.S

Alarm Assay reagent short; Diluent short; Pretreatment reagent short.

Description The liquid level cannot be detected in the reagent pack.

Cause o There is no reagent in the reagent pack, the assay reagent volume is insufficient.
o The diluent volume is insufficient.
o The pretreatment volume is insufficient.

Remedy 1 Verify that reagent, diluent, and pretreatment volumes are adequate. Replace the
low reagent, if necessary, and perform a reagent scan after the replacement.
2 If adequate reagent volumes are present, verify volumes on the Reagent screen.
3 Resume operation and rerun the sample.
4 If the alarm recurs, call Technical Support.

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Data alarms: general

Reag.T

Alarm Abnormal reagent disk temperature

Description Reagent rotor temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.

Cause o Radiation of heat does not work normally.

o The room temperature is out of range.

Remedy 1 Verify that the reagent rotor cover is securely in place.

2 Check the fans at the rear are operating normally and are free of obstructions.
3 Check that room temperature is between 18°C and 32°C.
4 If the alarm recurs, call Technical Support.

Samp.C

Alarm Sample clot

Description A sample clot is detected during aspiration.

Cause o The sample volume is insufficient.

o There are clots in the sample.

Remedy 1 Check sample volume, and fill the required volume in the sample container as
necessary.
2 Check the sample for fibrin. Remove any clots.
3 Rerun the sample.

Samp.S

Alarm Sample short

Description The sample volume is insufficient or missing.

Cause o The sample is missing from the sample disk.

o The sample volume is insufficient.

Remedy 1 Load the sample if it is not already on board.

2 Check sample volume, and fill the required volume in the sample container as
necessary. If the sample appears to be sufficient, contact Technical Support.
3 Rerun the sample.

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Data alarms: general

SLLD.E

Alarm Sample LLD abnormal

Description The S/R probe does not start liquid level detection (LLD) or LLD is not completed.

Cause o The S/R probe is dirty or wet.

Remedy 1 Clean and dry the S/R probe, and resume measurement.
2 If the alarm recurs, call Technical Support.

SLLD.N

Alarm Sample LLD noise

Description The S/R probe detects noise.

Cause There are bubbles in the sample container.

Remedy 1 Remove the bubbles with an applicator stick.

2 Rerun the sample.

SysR.S

Alarm System reagent short

Description Liquid short signal is detected, or the liquid level cannot be detected in the ProCell
reservoir.

Cause The volumes in the system reagent bottles (ProCell and CleanCell) are insufficient.

Remedy 1 Check levels in ProCell and CleanCell bottles, and replace as necessary.
2 Resume operation and rerun the sample.
3 If the alarm recurs, call Technical Support.

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Data alarms: general

SysR.T

Alarm System reagent temperature

Description ProCell/CleanCell temperature is out of range. The system performs an initial check
30 minutes after start-up and checks the temperature continuously thereafter.

Cause o Radiation of heat does not work normally.

o The room temperature is out of range.

Remedy 1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18°C and 32°C.
3 If the alarm recurs, call Technical Support.

SysR.U

Alarm System reagent temperature unstable.

Description System reagent temperature is unstable.

Cause ProCell/CleanCell temperature was unstable.

Remedy ProCell and CleanCell must be at 28°C before operation. Either bring the reagent to
temperature, or place it on the analyzer approximately 15 minutes before operation.

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Data alarms: controls and samples

Data alarms: controls and samples

>Ref

Alarm Outside of expected value (upper)

Description For patient samples, the calculated concentration is greater than the upper limit of the
expected value range.
For control samples, a concentration exceeded the 3 SD values specified on QC >
Install.

Cause o The sample concentration is higher than the expected value.

o A proper expected value range is not specified.

Remedy 1 Follow laboratory protocol for high samples.

2 Specify a proper range under Expected Values in Utility > Application > Range.

<Ref

Alarm Outside of expected value (lower)

Description For patient samples, the calculated concentration is less than the lower limit of the
expected value range.
For control samples, a concentration was less than the 3 SD values entered on QC >
Install.

Cause o The sample concentration is lower than the expected value.

o A proper expected value range is not specified.

Remedy 1 Follow laboratory protocol for low samples.

2 Specify a proper range under Expected Values in Utility > Application > Range.

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Alarm abbreviations and status conditions

Alarm abbreviations and status conditions

The cobas e 411 analyzer has a number of status conditions. The status conditions
usually seen during routine operation or maintenance procedures are listed below.

Abbreviations Alarm levels Status condition

E.Stop Emergency Stop An emergency stop condition exists. An alarm

was issued. Take the appropriate measures to
resolve the problem

Stop Stop This status occurs when Stop is pressed or when a

Stop alarm condition exists. If an alarm exists,
take the appropriate measures to resolve the
problem

P. Stop Partial Stop A partial stop condition exists. An alarm was

issued. Take the appropriate measures to resolve
the problem

A. Stop Analyzer Stop The system is no longer able to continue

operation. An alarm was issued. Take the
appropriate measures to resolve the problem

A. Stop/L. Stop Analyzer stop/ The system is already in A. Stop status when the
line stop lines stop operation

A. Stop/R. Stop Analyzer stop/ The system is already in A. Stop status when the
rack stop A-Line stops supplying racks to the B-Line

L. Stop Line Stop All lines stop operation. An alarm was issued.
Take the appropriate measures to resolve the
problem

S. Stop Sampling Stop This status occurs when S. Stop is pressed or

when sampling is complete

S. Stop-S.Scan The system is in S. Stop and a sample scan is

requested from the Status screen, or S is pressed
while the system is in S. Stop

R. Stop Rack Stop This status occurs when there are no more racks
to process on the A-Line or B-Line

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19 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-117
20 Laboratory exercises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-151
cobas e 411 analyzer 19 Maintenance
Maintenance items

Maintenance

Maintenance items

This section lists all maintenance items and a brief description of their function.

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Maintenance items

System Reset

Mechanical parts are reset to their home or standby positions. A system reset is often
necessary if the system is in a P. Stop or Stop status due to an alarm condition. This
button does not cause a reset of any of the line mechanisms on a rack system.
If the system stops during reagent scan or after start (because the PC/CC bottles are
not manually opened), a reset has to be done because the sipper needle is blocked.

Liquid Flow Cleaning

Sipper flow paths and measuring cell are washed with SysClean. The default number
is 1 cycle.

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Maintenance items

Sipper Pipetter Prime

Sipper flow paths are primed with system water, for the specified number of cycles.
The default number is 100 cycles. The number counts down until the last cycle is
completed.

S/R Pipetter Prime

Sample/Reagent pipetter flow path is purged with system water for the specified
number of cycles. This is necessary after changing pipetter seals. The default number
is 100 cycles. The number counts down until the last cycle is completed.

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Maintenance items

Measuring Cell Exchange

Sipper flow paths are rinsed with system water for the specified number of cycles and
then dried in preparation for a measuring cell exchange.

Measuring Cell Preparation

The measuring cell is conditioned, for the specified number of cycles. It is used to
prime the measuring cell with ProCell. The default number is 100 cycles. The number
counts down until the last cycle is completed.

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Maintenance items

Finalization Maintenance

The system and the sipper probe are primed with system water, and the measuring
cell is filled with ProCell. This function is automatically done from the system after
documentation of the last result.
The pump of the pipetter rinse station is activated every 30 minutes for 2 seconds.
The system water consumption is 12 mL per priming or 1 liter per week.
Exception: If the run is interrupted, the finalization process has to be started
manually.

Media Write

Use this window to write all data files currently stored in the system memory onto a
memory card (CF) internal device or on the DVD-RAM as external device.

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Maintenance items

L. and A. Reset All

Use this window to initiate a complete system and line reset for the rack analyzer A-,
B-, and C-lines, as well as returning all analyzer mechanisms to their home or
Standby positions.
An L. and A. Reset All is often necessary if the analyzer is in a Stop or P. Stop status
due to an alarm condition.

Rack Clear

Use this window to clear the B-line of any racks and transfer them to the C-line.

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Maintenance schedule

Maintenance schedule

The recommended schedule for all maintenance actions are listed in descending
frequency:

Procedure Maintenance items Operator time System time

(approx.) (approx.)
Daily Clean the sample/reagent probe (PO) 1 min —
Clean the direct drain flow path 5 min —
Perform finalization (PO) 30 sec 4 min
(* if system does not automatically
perform finalization status during run)
Weekly Clean the incubator and aspiration 5 min —
station (PO)
Clean the sipper probe (PO) 1 min —
Every two weeks Clean the rinse stations (PO) 7 min —
Perform liquid flow path cleaning (a) 4 min 17 min
(SB)
Every two months Replace the pinch valve tubing (SB/PO) 5 min 17 min
As needed Clean the system water container (SB/ 10 min —
PO)
Clean the liquid waste container (SB/ 5 min —
PO)
Clean the microbead mixer (SB/PO) 2 min —
Clean the ProCell and CleanCell 5 min —
compartments (SB/PO)
Clean the reagent rotor and 15 min —
compartment (SB/PO)
Empty the solid waste (SB/PO) 2 min —
Protect the measuring cell during — —
extended shutdown (SB/PO)
(a) Every two weeks or 2500-3000 cycles, whichever comes first.
PO Power OFF
SB Standby

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Daily maintenance

Daily maintenance

Clean the sample/reagent probe

Preventive action: Dirt on S/R probe may cause contamination and carryover, and affect results.
Take care not to bend the probe during cleaning.

Materials Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol

a Procedure
1 Switch off the system.
2 Move the S/R probe to an area where you can readily access it.
3 Wipe the outer surfaces of the S/R probe and probe tip with a gauze pad soaked in
distilled water.

A Sample/reagent probe B Sample/reagent probe tip

4 If the probe is still dirty, wipe the outer surfaces with a gauze pad soaked in 70%
isopropyl alcohol, then clean the outer surfaces with distilled water again.
5 Switch on the system.
A start-up reset operation is performed. Each mechanism returns to its home
position.

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Daily maintenance

Clean the direct drain flow path

Preventive action: If your cobas e 411 analyzer is equipped with the direct drain system, it is possible
that crystallization of waste solution in the flow path may cause clogging. To prevent
crystallization in the flow path, be sure to clean the flow path after each day's
operation.

Materials Item
Syringe with attached tubing (obtain locally)
Distilled or deionized water (approximately 100 ml)

a Procedure
1 Using a syringe with attached tubing, pour approximately 100 cc of distilled water
into the reserve tank inlet.

B
A Direct drain reserve tank inlet B Direct drain tube

2 Check whether the water flows without stagnation. If the flow stagnates, check the
condition of the drain tube. If the tube is clogged, contact your local Roche service
representative. Do not try to remove the clogging yourself.
3 Wipe the outer surfaces of the S/R probe and probe tip with a gauze pad soaked in
distilled water.

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Daily maintenance

Perform finalization step

Preventive action: Only essential if the last run was not completed properly (alarm issued).
The Finalization step has to be executed manually. During finalization, the system is
primed with water, and the measuring cell is filled with ProCell.

Materials None.

a Procedure
1 Choose Utility > Maintenance.
2 Select Finalization (6) in the Maintenance Items list.
3 Choose Select to display the Finalization Maintenance window.
4 Choose Execute to perform the Finalization Maintenance process.

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Weekly maintenance

Weekly maintenance

Clean the incubator and aspiration station

Preventive action Spills on the incubator may cause gripper movement alarms.

Materials Item
Gauze pads
Cotton swabs
Distilled water

a Procedure
1 Switch off the system.
2 Move the S/R probe arm to the far left.
3 Move the gripper towards the front of the analyzer.
4 Move the sipper arm to the far right.
5 Clean the top of the incubator and aspiration station with distilled water.
6 If incubator or aspiration station is still dirty, use a slight scrubbing motion with
the water-soaked gauze pads.
7 Wet a cotton swab with distilled water and swab each of the 32 incubator positions
and aspiration station.

A B C
A Wipe incubator surface B Swab incubator positions
C Aspiration station

8 Dry the incubator with a dry gauze pad after cleaning.

9 Switch on the system.
A start-up reset operation is performed. Each mechanism returns to its home
position.

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Weekly maintenance

Clean the sipper probe

Preventive action Dirt on the sipper probe may cause contamination and carryover, thereby affecting
results.
Take care not to bend the probe during cleaning.

Materials Item
Gauze pads
Cotton swabs
Distilled water

a Procedure
1 Switch off the system.
2 Lift the instrument cover.
3 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.

4 Move the sipper probe to an area where it can easily be cleaned.

5 Wipe the outer surfaces of the sipper probe with a gauze pad soaked in 70%
isopropyl alcohol, then wipe it with a gauze pad soaked in distilled water.

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Weekly maintenance

A
B

A Sipper probe B Sipper probe rinse station

6 Close the sipper shield until the latch is engaged and you hear a click.
7 Clean the top of the incubator and aspiration station with distilled water.
8 Switch on the system.
A start-up reset operation is performed. Each mechanism returns to its home
position.

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Every two weeks maintenance

Every two weeks maintenance

Clean the rinse stations

Preventive action The system has one rinse station for the sample/reagent probe and bead mixer, and
one for the sipper probe.
Contamination in the rinse stations can be responsible for carryover.

Materials Item
Cotton swabs
Distilled water (approx 300 mL)
Syringe with attached tubing
70% isopropyl alcohol

a Procedure
1 Switch off the system.
2 Move the S/R probe, microbead mixer, and the sipper probe to an area away from
the rinse stations.

A Microbead mixer arm (being moved) B Rinse station

C Sipper probe (moved)

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Every two weeks maintenance

3 Take a syringe with tubing attached and aspirate the water out of the mixer rinse
station.

A BC D E
A Microbead mixer B Sample/reagent probe rinse station
C Microbead mixer rinse station D Attached tube
E Syringe

4 Use a cotton swab soaked in 70% isopropyl alcohol to thoroughly clean the mixer
rinse station and the sipper rinse stations.

A
B

A Swab B Rinse station

5 Afterwards, wipe the rinse stations with distilled water.

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Every two weeks maintenance

6 Fill the syringe with distilled water, and refill the mixer rinse station (takes
approximately 50-100 mL of water).
7 Flush the S/R probe and sipper rinse stations with water (50-100 mL).
8 Aspirate water out of the mixer rinse station again, by using the syringe.
9 Refill the mixer rinse station, and flush all the rinse stations with distilled water
again.
10 Switch on the system.
A start-up reset operation is performed. Each mechanism returns to its home
position.

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Every two weeks maintenance

Liquid flow cleaning

This maintenance task is divided into the following procedures:

1. Perform pre-cleaning
2. Initiate Liquid flow cleaning
3. Perform post-cleaning steps
Take care to perform the procedures in the correct order.

Preventive action To keep the sipper liquid flow path clean and maintain the integrity of the measuring
cell, perform liquid flow path cleaning.

Materials Item
SysClean (cat. no. 11298500)
SysClean adapter (cat. no. 1933159)
Distilled water

a Procedure 1: To perform pre-cleaning

1 Remove ProCell bottle from position 3.
2 Fill the 'USER' compartment/SysClean adapter with SysClean reagent. The
compartment holds approximately 9 mL of fluid.
3 Insert the filled SysClean adapter into position 3 with the edge marked 'USER'
facing the back of the system.

A B

A USER compartment of the SysClean adapter B Ledge of the USER compartment

4 Remove the liquid waste container and clean it with distilled water.
5 Replace the liquid waste container again.
6 Check that ProCell and CleanCell bottles are in positions 1, 2, and 4.

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Every two weeks maintenance

7 Check the bottle lids are open and that there is enough liquid.

a Procedure 2: To initiate Liquid flow cleaning

1 Choose Utility > Maintenance.
2 Choose Maintenance from the Maintenance Type list.
3 Select Liquid Flow Cleaning from the Maintenance Items list.
4 Choose Select to display Liquid Flow Cleaning window.

5 Type 1 in the Cycles text box and choose Start.

a Procedure 3: To perform post-cleaning steps

1 When Standby is displayed, remove the liquid waste container and rinse it with
distilled water.
2 Remove and rinse the SysClean adapter.
3 Return the ProCell bottle to position 3.

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Every two months

Every two months

Replace the pinch valve tubing

This maintenance task is divided into the following procedures:

1. Purge the tubing of liquid
2. Remove the tubing from the fittings
3. Replace a broken fitting (optional—only perform if necessary)
4. Prime the sipper and measuring cell
Take care to perform the procedures in the correct order.

Preventive action Worn pinch valve tubing can allow liquid to leak out. Leakage will affect both the
accuracy of the pipetting volumes and the ability of the system to properly clean the
measuring cell.

Materials Item
Gauze pads
Pinch valve tubing (cat. No. 741-1592 (1m))
Tube joint B
Paper towels

a Procedure 1: To purge the tubing of liquid

1 Choose Utility > Maintenance >.
2 Choose item Measuring Cell Exchange and choose Select to open the MC
exchange window.
3 Choose Start. The tubing is purged of liquid.
4 When system returns to Standby, switch off the system.

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Every two months

a Procedure 2: To remove the tubing from the fittings

A E

B F

C G

D H

A Pinch valve (left side, sample/reagent probe) B Tubing (left side, sample/reagent probe)
C Fitting (sample/reagent probe) D Fitting (sample/reagent probe)
E Pinch valve (right side, sipper probe) F Tubing (right side, sipper probe)
G Fitting (sipper probe) H Fitting (sipper probe)

1 Remove the system water container.

2 Cover the area below the pipetters with paper towels to prevent spillages and
potential contamination.

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Every two months

3 Remove the tubing from the fittings and discard.

Liquid that flows through this tubing comes from the measuring cell and is
potentially biohazardous.

4 Remove the tubing from the pinch valve and discard.

5 Insert the tubing through the pinch valve.

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A B

A Pinch valve B Tubing

6 Slide the ends of tubing over each of the fittings in turn.

A B

A Fitting B Tubing

7 Repeat the procedure for the other pinch valve tubing.

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Every two months

a Procedure 3 (optional): To replace a broken fitting (if necessary)

1 Screw out the fitting counterclockwise from the valve block.

A
B
C

A Fitting B O-ring
C Valve block

2 Screw the new fitting (Tube joint B) in clockwise.

3 Repeat steps 1 to 2 if any other fittings are broken.
4 Continue with the replacement procedure.

a Procedure 4: To prime the sipper and measuring cell

1 Switch on the system.
2 Choose Utility > Maintenance > Sipper Prime.
3 Type the number of priming cycles (10).
4 Choose Start.
The sipper system is purged of air.
5 While the system is priming, check for leaks at the fittings and on the tubing.
6 After the sipper prime is finished, select Utility > Maintenance > MC Preparation.
7 Type 10 in the Prime Cycles text box.
8 Choose start
The system begins priming the sipper and measuring cell with ProCell.
9 While the system is priming, check for leaks at the fittings and on the tubing.
Priming is complete when the system returns to Standby.

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As needed maintenance

As needed maintenance

Clean the system water container

Preventive action A contaminated system water (distilled water) container can adversely affect analyzer
performance.

Materials Item
Gauze pads
Cleaning brush
Distilled water
Paper towels
70% isopropyl alcohol

a Procedure
1 Switch on the system (Standby mode).
2 Remove the system water container.

A Cap and valve (not visible) B System water container

3 Discard any water remaining inside.

4 Rinse the container with water, and then rinse with distilled water.
5 If the container is still dirty or contaminated, use a large cleaning brush immersed
in 70% isopropyl to scrub the interior of the container. Then rinse the container
with water and rinse with distilled water.
6 Remove the valve on the bottom of the system water container.

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cobas e 411 analyzer 19 Maintenance
As needed maintenance

7 Clean the valve with a wet brush, then rinse with distilled water.
8 If the valve is still dirty, clean it with 70% isopropyl alcohol and then with distilled
water.
9 Clean the aspiration inlet for the distilled water supply with a gauze pad.

A Aspiration inlet

10 Connect the valve to the container bottom and fill the container with distilled
water.
11 SysWash has to be added: (1+100). Add 35 mL of SysWash to the distilled water,
pouring carefully to avoid creating air bubbles.
12 Dry the outside of the container and attach the cap.
13 Return the container to the system.

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As needed maintenance

Clean the liquid waste container

Preventive action A full liquid waste container causes an alarm and interrupts the operation of the
system. This applies to the internal liquid waste container, and also to any external
liquid waste tank in cases where the optional direct drain arrangement is used.

Materials Item
Paper towels
70% isopropyl alcohol
Germicidal agent, pH 9 (optional)

a Procedure
1 Switch off the system or put into Standby mode.
2 Pull the liquid waste container toward you, cap it, and raise it carefully while
avoiding the liquid waste outlet.

3 Empty the container and rinse it with water.

4 If the container is still dirty, use 70% isopropyl alcohol to rinse the container then
rinse with distilled water.
5 Wipe the outside of the container and the compartment with a paper towel.
6 Optional step: Add the appropriate volume of a germicidal agent of pH 9 (as
directed in its product labeling) to the liquid waste container.
7 Remove the paper towel under the waste outlet and replace the liquid waste
container.
8 Push the container forward so that the container opening is under the liquid waste
outlet. Be sure to remove the cap.

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cobas e 411 analyzer 19 Maintenance
As needed maintenance

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19 Maintenance cobas e 411 analyzer
As needed maintenance

Clean the microbead mixer

Preventive action Check the microbead mixer periodically, and clean the mixer if you see dirt, for
example red dots, on the mixer arm or the paddle. Impurities on the microbead mixer
may cause problems and affect results.

Materials Item
Gauze pads
Distilled water
70% isopropyl alcohol

a Procedure
1 Switch off the system or put into Standby mode.
2 Move the microbead mixer arm to a position where you can readily access it.

A Mixer paddle

3 Taking care not to bend the mixer paddle, carefully wipe the outer surface of the
bead mixer paddle with a gauze pad soaked in 70% isopropyl alcohol, and then
repeat with distilled water
4 Switch on the system.
A start-up reset operation is performed. Each mechanism returns to its home
position.

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cobas e 411 analyzer 19 Maintenance
As needed maintenance

Clean the ProCell and CleanCell compartments

Preventive action Clean the system reagent compartment to eliminate any liquid or residue spilled from
the ProCell and CleanCell reagents.

Materials Item
Gauze pads
Distilled water
70% isopropyl alcohol

a Procedure
1 Switch off the system or put into Standby mode.
2 Lift the instrument cover.
3 Open the sipper shield until the latch is released.
4 Move the sipper arm manually as far to the left as the arm will allow.
5 Remove all four system reagent bottles from their compartments.
6 Wipe the sipper shield with a damp gauze pads and repeat with a dry gauze pad.

A Sipper shield latch B Sipper shield (in the open position)

7 Wipe the inside of the compartments with damp (not wet) gauze pads. Do not
allow water to pool in the bottom of the compartments.

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As needed maintenance

B C
A Photosensor locations (visible when bottle B Bottle set 2, CleanCell position
removed)
C Bottle set 1, ProCell position

8 Wipe the compartment with a dry gauze pad.

9 Return the system reagents to the compartments.
10 Close the sipper shield until the latch is engaged and you hear a click.
11 Close the instrument cover.
12 Switch on the system.
A start-up reset operation is performed. Each mechanism returns to its home
position.

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cobas e 411 analyzer 19 Maintenance
As needed maintenance

Clean the reagent rotor and compartment

This maintenance task is divided into the following procedures:

1. Clean the reagent rotor
2. Clean the reagent rotor compartment
Take care to perform the procedures in the correct order.

Preventive action The reagent rotor and compartment must be cleaned as soon as any signs of dirt or
contamination appear.

Materials Item
Gauze pads
Distilled water
70% isopropyl alcohol
Cloth or lint-free towels

a Procedure 1: To clean the reagent rotor

1 Switch off the system.
2 Remove the cover from the reagent rotor.
3 Loosen and remove the black thumbscrews of the reagent rotor.
4 Close all the reagent pack caps and remove all the reagent packs.
5 Remove the reagent rotor from the compartment.

B
A Thumbscrews B Alignment pin

6 Wipe the inside and the outside of the reagent rotor with distilled water.

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As needed maintenance

A Compartment B Body of the disk

7 If the reagent rotor is still dirty, clean it with 70% isopropyl alcohol and then with
distilled water.
8 Dry the reagent rotor with a cloth or lint-free towels.

a Procedure 2: To clean the reagent rotor compartment

1 Ensure that the system is switched off.
2 Wipe the reagent rotor compartment with distilled water.

A
A Reagent rotor compartment

3 If the reagent rotor is still dirty, clean it with 70% isopropyl alcohol and then with
distilled water.

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cobas e 411 analyzer 19 Maintenance
As needed maintenance

4 Dry the reagent rotor compartment with a cloth or lint-free towels.

5 Return the reagent rotor, making sure that the alignment pin on the center plate is
aligned with the hole on the rotor.
6 Reinstall the thumbscrews.
7 Place the reagent packs back into the reagent rotor.
8 Replace the reagent rotor cover.
9 Switch on the system.
A start-up reset operation is performed. Each mechanism returns to its home
position.

Empty the solid waste

Preventive action During operation, the solid waste tray is filled with disposed tips and cups.
Check the solid waste tray regularly, and empty as needed.

Materials Item
Clean-Liner (cat. No. 11800507-001)

a Procedure
1 Switch off the system or put into Standby mode.
2 Open the solid waste door and pull out the tray.
3 Slide the lid forward to close the Clean-Liner.

A Sliding lid B Solid waste compartment door

C Waste tray

4 Remove the Clean-Liner and dispose of it according to the waste handling and
disposal procedures that apply in your laboratory.

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As needed maintenance

5 Place a fresh Clean-Liner into the tray.

6 Make sure that the sliding door is open and that the opening is located at the back
of the tray.
7 Insert the tray and close the door.

The software counts the tips and cups used during operation. When the system senses that the solid
waste tray was removed, the counter resets to 0.

8 Switch on the system. A start-up reset operation is performed. Each mechanism

returns to its home position.

Protect the measuring cell during extended shutdown

Preventive action If the system is not going to be used for more than seven days, it is important to
ensure that the system is properly prepared and that the correct shutdown
maintenance has been performed. Failure to observe these recommendations may
result in damage to the measuring cell.
Different shutdown procedures are recommended, depending upon the duration of
inactivity. Certain procedures may require the assistance of a Roche Diagnostics
service representative.

Shutdown period Shutdown procedure Startup process

One week No special action necessary after operation No special action
One to four weeks After operation, perform a sipper prime (5 times) Perform measuring
to fill the measuring cell with system water. The cell preparation (30
measuring cell will remain in the system. times).
Four weeks and After operation, perform a sipper prime (5 times) Perform measuring
longer to fill the measuring cell with system water. Seal cell preparation (30
the sipper probe by using flexible tubing. The times).
measuring cell will still remain in the system.

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cobas e 411 analyzer 20 Laboratory exercises
Exercise 18: Maintenance

Laboratory exercises

Exercise 18: Maintenance

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Knows the schedule for all maintenance actions
o Perform the daily, weekly, and two-weekly maintenance procedures
Daily Weekly Two-weekly

Exercises

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cobas e 411 analyzer 20 Laboratory exercises
Exercise 18: Maintenance

Match the following:

A Liquid Flow Cleaning Finalization maintenance

B Clean Sample/Reagent probe System Reset

C As needed Every two-week with SysClean

D Sipper needle is blocked Daily maintenance

E If the run is interrupted, process has to Are used to verify calibration curve
be started manually

Quiz

Mark each of the following statements with a l if true:

System reset does include a reset for line mechanisms on a rack system

The weekly maintenance should be done in Power Off mode

The SysWash solution is used for the “Liquid Flow Cleaning” maintenance

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21 Ordering list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-3

cobas e 411 analyzer 21 Ordering list
Reagents and calibrators

Ordering list

Reagents and calibrators

Reagent type Test Tests Number of CalSet

Cat.no. determinations per Cat.no.
reagent pack
Thyroid FT3 03051986-190 200 03051994-190
FT4 11731297-122 200 11731661-122
T3 11731360-122 200 11731548-122
T4 12017709-122 200 12017717-122
TSH 11731459-122 200 04738551-190
T-uptake 11731394-122 200 11731505-122
TG 11820834-122 100 11820940-122
Anti-TG 04738578-190 100 ♣
Anti-TPO 11820818-122 100 ♣
Cardiac CK-MB STAT 11731432-122 100 11731572-122
CK-MB 11821598-322 100 11821601-122
Digoxin 11820796-322 100 11820907-122
Digitoxin 03002659-122 100 03002667-122
Myoglobin STAT 11820788-122 100 11820893-122
Myoglobin 12178214-122 100 12178222-122
proBNP 03121640-122 100 03121658-122
Troponin T STAT 04660307-190 100 04856643-190
Troponin T 04491815-190 200 04856627-190
Hormones ACTH 03255751-190 100 03255760-190
Cortisol 11875116-122 100 11875124-122
DHEAS 03000087-122 100 03000095-122
Estradiol II 03000079-122 100 03064921-122
FSH 11775863-122 100 03032680-122
HCG STAT 03300811-190 100 03303071-190
HCG+beta 03271749-190* 100 03302652-190
LH 11732234-122 100 03561097-190
Progesterone II 12145383-122 100 12145391-122
Prolactin II 03203093-190 100 03277356-190
SHBG 03052001-190 100 03052028-190
Testosterone 11776061-122 100 03005658-122
Legend:
♣ Calibrators (1 bottle CalSet 1 and 1 bottle CalSet 2) and Controls (2 levels, each level 1 bottle) are parts of the test kit.
∅ No dilution possible
♦ Pretreatment Assay (27 min. duration time)
• Qualitative assay

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cobas e 411 analyzer 21 Ordering list
Reagents and calibrators

Reagent type Test Tests Number of CalSet

Cat.no. determinations per Cat.no.
reagent pack
Diabetes C-Peptide 03184897-190 100 03184919-190
Insulin 12017547-122 100 12017504-122
Tumor marker AFP 04481798-190 100 04487761-190
CA 125 II 11776223-322 100 11776240-322
CA 15-3 II ∞ 03045838-122 100 03045846-122
CA 19-9 11776193-122 100 11776215-122
CA 72-4 11776258-122 100 11776274-122
CEA 11731629-322 100 11731645-322
Cyfra 21-1 11820966-122 100 11820974-322
NSE 12133113-122 100 12133121-122
Free PSA 03289788-190 100 03289796-190
Total PSA 04641655-190 100 04485220-190
S100 03175243-190 100 03289834-190
Anemia Vitamin B12 ♦ 04745736-190 100 04572459-190
Ferritin 03737551-190 100 03737586-190
Ferritin 04491785-190 200 03737586-190
Folate II ♦ 03253678-122 100 04476441-190
RBC Folate 12017741-122 4*200 mL -
Bone ß-CrossLaps 11972308-122 100 11972316-122
N-MID Osteocalcin 12149133-122 100 11972111-122
Total P1NP 03141071-190 100 03141080-190
PTH 11972103-122 100 11972219-122
Varia IgE 11930419-122 100 11930427-122
Hepatitis Anti-HAV 11820605-122 100 -
Anti-HAV IgM ∅ • 11820591-122 100 -
Anti-HBc ♦ • 11820559-122 100 -
Anti-HBc IgM ∅ • 11820567-122 100 -
Anti-HBe • 11820613-122 100 -
HBeAg • 11820583-122 100 -
Anti-HBs 11820524-122* 100 -
HBsAg • 11820532-122 100 -
HBsAg Confirmatory 11820648-122 2*10-15 -
Retro-viruses HIV Antigen • 11971611-122 100 -
HIV Antigen 12001101-122 2*20 -
Confirmatory
HIV combi 03599604-190 100 -
Legend:
♣ Calibrators (1 bottle CalSet 1 and 1 bottle CalSet 2) and Controls (2 levels, each level 1 bottle) are parts of the test kit.
∅ No dilution possible
♦ Pretreatment Assay (27 min. duration time)
• Qualitative assay

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cobas e 411 analyzer 21 Ordering list
Controls

Controls

PreciControls Package content Cat.no.

Universal 2 levels, each level two bottles 11731416-122
Cardiac 2 levels, each level two bottles 03530477-190
MultiAnalyte 2 levels, each level two bottles 03609979-190
ACTH 2 levels, each level two bottles 04655346-190
TNT 2 levels, each level two bottles 03530469-190
TSH 1 level, four bottles 11776479-122
Tumor marker 2 levels, each level two bottles 11776452-122
S100 2 levels, each level two bottles 03330648-190
Bone 3 levels, each level two bottles 11972227-122
Anemia 3 levels, each level two bottles 04415299-190
Anti-TG 2 levels, each level one bottle ∇ Controls are part of the test kit.
Anti-TPO 2 levels, each level one bottle ∇ Controls are part of the test kit.
Anti-HAV 2 levels, each level eight bottles 11876350-122
Anti-HAV IgM 2 levels, each level eight bottles 11876368-122
Anti-HBc 2 levels, each level eight bottles 11876325-122
Anti-HBc IgM 2 levels, each level eight bottles 11876333-122
Anti-HBe 2 levels, each level eight bottles 11876384-122
HBeAg 2 levels, each level eight bottles 11876376-122
Anti-HBs 2 levels, each level eight bottles 11876317-122
HBsAg 2 levels, each level eight bottles 11876309-122
HIV Ag 2 levels, each level eight bottles 11971735-122
HIV combi 3 levels, each level five bottles 03599612-190

Diluents

Diluents Cat.no. Package content

Universal 11732277-122 2 bottles, 16 (18) mL each
Universal 03183971-122 2 bottles, 36 (40) mL each
MultiAssay 03609987-190 2 bottles, 16 (18) mL each
NSE 03004864-122 4 bottles, 3 mL each
Hepatitis A 11361252-122 2 bottles, 15 mL each

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21 Ordering list cobas e 411 analyzer
System reagents

System reagents

System Cat.no. for cobas e 411 analyzer Package content

reagents Elecsys 1010/2010
ProCell 11662988-122 6 bottles, 380 mL each
CleanCell 11662970-122 6 bottles, 380 mL each
SysWash 11930346-122 1 bottle, 500 mL
SysClean 11298500-316 5 bottles, 100 mL each

System accessories

System accessories Cat.no. for cobas e 411 Package content

analyzer
Elecsys 1010/2010
Tips 11706799-001 30 x 120 tips
Cups 11706802-001 60 x 60 cups
Clean-Liner 11800507-001 1 * 14 bags
CalSet Vials 11776576-322 2 x 56 bottles
Control Vials 03142949-122 2 x 56 bottles
SysClean Adapter 11933159-001 1 piece
Elecsys® 1010/2010/cobas e 411

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cobas e 411 analyzer 21 Ordering list
Racks for samples, calibrators, and controls

Racks for samples, calibrators, and controls

Item ID-no. Range Size

RD Standard Rack 1 902 997 0001 - 0050 (50 pc/package)
RD Standard Rack 1 903 004 0051 - 0100 (50 pc/package)
RD Standard Rack 1 903 012 0101 - 0150 (50 pc/package)
RD Standard Rack 1 903 039 0151 - 0200 (50 pc/package)
RD Standard Rack 1 903 047 0201 - 0250 (50 pc/package)
RD Standard Rack 1 903 055 0251 - 0300 (50 pc/package)
RD Standard Rack 1 903 063 0301 - 0350 (50 pc/package)
RD Standard Rack 1 903 071 0351 - 0400 (50 pc/package)
RD Standard Rack 1 903 080 0401 - 0500 (100 pc/package)
RD Standard Rack 1 903 098 0501 - 0600 (100 pc/package)
RD Standard Rack 1 903 101 0601 – 0700 (100 pc/package)
RD Standard Rack 1 903 128 0701 - 0800 (100 pc/package)
RD Standard Rack 1 903 136 0801 - 0900 (100 pc/package)
RD Standard Rack 1 903 144 0901 – 1000 (100 pc/package)
RD Standard Rack 1 906 747 2001 – 2100 (100 pc/package)
RD Standard Rack 1 906 828 2101 – 2200 (100 pc/package)

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Racks for samples, calibrators, and controls

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 Laboratory exercises H

22 Answers to laboratory exercises . . . . . . . . . . . . . . . . . . . . . . . . . H-3

cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 1: System overview

Answers to laboratory exercises

Exercise 1: System overview

Perform the following exercises using the cobas e 411 analyzer Training Guide as a
reference. For more detailed information, refer to the How to... chapter of the
cobas e 411 analyzer Operator’s Manual.

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Describe the main components of the cobas e 411 disk and rack analyzers

Exercises

B Sample/
reagent area

D Consumables
and liquid
waste area

A Operation
switch
E
F Main circuit
breaker
(hidden)

E Control unit

C Measuring
area
F

A B C D

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 1: System overview

E STAT (Short
Turn Around
Time)
position
A
B C B-Line
(hidden)

B A-Line
C
D C-Line

A Rack sampler
circuit breaker
D

Quiz

Mark the correct sequence of system reagent in the figure above with a l

Position 1, 2, 3, and 4 starting on the left hand side

Position 1, 2, 3, and 4 starting on the right hand side

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 2: System overview

Exercise 2: System overview

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Classify the pictures as components of either the disk or rack system
o Know the specification of the cobas e 411 analyzer

Exercises

Sample flap

Sample/Reagent area: sampler for samples, calibrators, and controls

Tray Tray Tray

Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication
light
B-Line

5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
tray
indication
light
STAT

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Exercise 2: System overview

Quiz

Mark each of the following statements with a l if true for the cobas e 411
specifications:

PC with touch screen and without external keyboard

Cobas host protocol do not upload the results of Calc tests

A protection cover is located on the sipper and pipetter area

Up to 15 reagent packs can be placed into the reagent rotor

Solid waste tray and liner can be not be replaced during the run

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 3: ECL technology, test overview, and principles

Exercise 3: ECL technology, test overview, and principles

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Knows the basic and principles of the immunoassay technology

Exercises

Which test principle is explained below?

Bridging
principle

Sandwich
principle

Competitive
principle

Match the following:

A ProCell
H ECL

B Measuring cell
E B12

C KOH- cleaning solution

B 42 second cycle

D Large molecular weight antibodies

F Competitive principle

E Pre-treatment test
A TPA

F Indirectly proportional measurement

D Anti-HBc IgM

G STAT test
C CleanCell

H Electrically chemiluminescent reaction

G beta-hCG

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 3: ECL technology, test overview, and principles

Quiz

Mark each of the following statements with a l if true:

9-minute tests: two incubation periods, each of 4.5 minutes

18-minute tests: three incubation periods, each of 4.5 minutes

27-minute tests: three incubation periods, each of 9 minutes duration

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 4: Reagent concepts

Exercise 4: Reagent concepts

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Understand the reagent concept basics
o Know about the correct handling of reagents

Exercises

The e-pack consists of three bottles. Which of the three bottles contains the
microbeads?

R1 bottle with a grey lid

R1 R2
M R2 bottle with a black lid

M bottle with a transparent lid

Match the following:

A Test code number

I 30 x 120

B Reagent packs
H Package inserts

C 2D matrix barcode
A Host

D Reagent barcode number

C Diluent reagent packs

E Calibrator and QC cards

B Ready to use

F cobas Link
F Test parameter download

G Highest priority rule

G Manually entered control

H Provides detailed information

D Manual input possible

I AssayTips cobas e 411

E Target values

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 4: Reagent concepts

Quiz

Mark each of the following statements with a l if true for system reagents:

CleanCell is stable on board for three days

SysClean avoids reagent carryover and prevents bacterial growth

ProCell is used for washing the streptavidin-coated microbeads

SysWash sodium hypochlorite solution is used for liquid flow cleaning maintenance

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Exercise 5: Calibration concepts

Exercise 5: Calibration concepts

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Knows about the correct handling of calibrators
o Understand the basic calibration rules
o Interpret the calibration results
o Remedy the situation of calibration causes

Exercises

C Calibrator barcode cards

A Empty calibrator vials to be

filled for CalSet 1 and 2

D Package inserts

E Extra labels for calibrator

aliquots

B Bottles containing calibrators to

be reconstituted
C

D
B

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Exercise 5: Calibration concepts

The example calibration criteria below applies to which test type?

Qualitative tests

Or
Quantitative tests

Match the following:

A Lot calibration
F Automatic calibration request

B Calibration criteria
D Cutoff assay

C Calibration stability
A Valid for all other reagent packs of the same lot

D Minimum/maximum signal
H Controls are outside of confidence limit

E Reagent pack calibration

B Calibration factor

F Change over
I Expired CalSets

G Failed calibration
C 28 days

H QC violation
E More than 24 hours

I Cannot be used
G Calibration causes

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 5: Calibration concepts

Quiz

Mark each of the following statements with a l if true for the calibration concept:

All of the calibrators are lyophilized in glass bottles and must be reconstituted

TSH calibrators are ready to use and stable on board for five hours

A reagent pack that has expired gets a reagent pack calibration only

Calibration is carried out in single determination

Minimum signal: if one or more calibrators are below the recommended minimum
signal level, the calibration is failed (red)

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Exercise 6: Quality control concepts

Exercise 6: Quality control concepts

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Understand the basics of the quality control concept
o Knows about the correct handling of controls

Exercises

A Empty control vials for level 2

F Package inserts

C Bottles containing controls for

level 2 to be reconstituted

E Control barcode cards

A G Extra labels for control

aliquots
B E
D Bottles containing controls for
level 1 to be reconstituted
C
D F B Empty control vials for level 1

Match the following:

A C-Peptide
F Target value

B Controls
D hCG-beta test

C PreciControl TSH
A PreciControl MultiAnalyte

D Lyophilized
C Ready to use

E Control barcode card

B Are used to verify calibration curve

F To be recovered within a defined range

E Priority 3

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 6: Quality control concepts

Quiz

Mark each of the following statements with a l if true for the quality control concept:

In the daily routine, QCs are used to monitor the accuracy and precision of the tests

If a target value of calibrator is entered manually, this value is valid until a new lot is
installed
The target values of the controls have to be recovered within a defined range

There are two basic possibilities to perform QC measurements: timeout and QC

violation

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 7: Start up and routine operation

Exercise 7: Start up and routine operation

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Perform correct start-up procedures
o Demonstrate proper reagent handling
o View messages, colors, and alarms before and during the run
o Print the reagent load list
o Delete open requisition

Exercises

o Switch on the printer, system and control unit

Check that:
Perform correct start-up o The indicator lights are on
procedures o There is sufficient paper in the printer
o Probes, pipetting station and incubator are clean
o Pipetters are bubble free
o Type the operator ID in the Operator ID text box.
o Type the password in the Password Text box.
o Touch log on
Log on with your Operator
o The operator ID is displayed in the status line
ID name
o Check the inventory for all of the reagents are on board,
and troubleshoot any events that are displayed
Demonstrate proper reagent Check the following:
handling and o System reagents: ProCell, CleanCell and open the lid
check the graphical inventory o Fill system water (3 L distilled water + 35 mL SysWash)
or reagent list o Empty liquid waste container and solid waste tray
o Check tips and cups

o Touch global button Alarm button and check the systems

instrument for any alarms
o Touch Alarm button from the graphical inventory
View messages, colors, and
o Check the temperature under the graphical inventory
alarms during the run in case
of trouble
o Touch Reagent Load List button from the System
Overview or touch global button Print/Reagent tab
o Print the reagent load list and check the information
Print the reagent load list
o Touch the Print View button from System Overview
o Before beginning, check whether data should be backed
up first
o Check if measured patients are documented (send to
Delete open requisitions
host)
o Touch the Sample Data Clear button from System
Overview or Workplace/Data Review button and press
delete All

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 8: Start up and routine operation

Exercise 8: Start up and routine operation

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Program routine (primary tubes with barcode labels)
o Program routine (cups without barcode labels and use the reduced type)
o Deal with auto diluents for a test
o Printing the work list and inventory list and use the print view as well
o Track sample progress through the run

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 8: Start up and routine operation

Exercises

Use different fields for running five samples:

o STAT and routine tab
Program routine o Sample type serum
(primary tubes with barcode o Sample ID number from the barcode label
labels) o Sample volume (dilution factor) for a test

Deal with auto diluents for a

test
Use different fields for running two samples:
o Routine tab
Program routine (cups o Sample type urine
without barcode labels) o Patient name
o

o For disk systems, use the Disk ID (non-barcode mode)

o For rack systems, use the Rack ID (non-barcode mode)

o Use “reduced minimum sample volume”
o Touch the global Print button and select the work list and
inventory list to print the data
o Check the lists and troubleshoot if necessary
Printing the work list and
inventory list and use the
print view as well
o Touch Sample Tracking button from System Overview
o Check the sample status
Track sample progress o
through the run

o For disk system results for each sample in positions 1 to

30 on the sample disk (multiple or single disk use)

o For rack system results for each sample in the output

buffer contains five racks, each containing five sample
positions

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 9: Start up and routine operation

Exercise 9: Start up and routine operation

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Review results relating to system alarms and data flags
o Print result report

Exercises

View the results from different screens for evaluation:

o Sample tracking screen
Review results relating to o Alarm screen, leave alarm messages until result
system alarms and data flags evaluation is finished completely
o Workplace/Data Review screen
o Workplace/Data Review/Test Review screen
o Workplace/Data Filter function
If a flag appears, troubleshoot the corresponding condition
using the Training Guide/Troubleshooting/Data Alarms
and Help function from the user interface

o Print the Result Report-normal format

o Result Report-condensed format
o Use Print View button as well from the System Overview
Print result report

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 9: Start up and routine operation

Quiz

Mark each of the following statements with a l if true for startup and routine
operation:

Switch on the cobas e 411 analyzer with the main circuit breaker

To log on with an operator ID, access level has to be defined with a minimum of one
access level for a operator ID
ProCell and CleanCell bottle lids have to be closed before starting

This icon means that the reagent in the graphical inventory has expired

Sample mix mode (samples with and without BC labels) is not allow during a run

>Ref/<Ref flags are belonging to control flags only

Sample signals can viewed on the Test Review screen and on the Result Report

n AM status Flag is visible in Test Review if an abnormality appears during

processing. This means that the test is still ordered but the reagent pack is not on
board or is empty. Therefore the test could not be performed.

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Exercise 10: Adding new tests to the system

Exercise 10: Adding new tests to the system

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Program the cobas e 411 analyzer for a new test

Exercises

Register the new reagent on the system

o Load the new reagent pack and open the reagent lids
slightly
o Perform a REAGENT SCAN from the Reagent menu or
System Overview screen
Scan barcode card for the calibrators of the new test
o Place the card into the reading position correctly
o Touch Calibrator/Install/BC Card Scan
o Do not remove the card until the status line displays
Standby mode
Activate the test to the belonging control
o If the control card for that particular test is already
installed, activation of the test is essential
o Touch Control/Install and activate the new test for the
specific controls and press save
Configure the test application settings
o Touch Utility/Application
o Select the new test verify the test settings
o Go to Utility/Application/Analyze and check if the default
diluent ratio or if an other diluent factor should be used
for the first result measurement
o Use the TG/Reagent Concept chapter/Universal Diluent
or MultiAssay (MA) recommendation list
o Go to Utility/Application/Calib. and change the settings
of Daily Calibration and Duplicate Limit % if necessary
o Decide the calibration workflow options whether
Timeout or QC Violation is used for the trigger of the
calibration cause
O If Timeout is preferred, choose OFF for QC Violation
O If QC violation is preferred, choose ON for QC
Violation
o Decide the QC Violation rule settings: 1, 2, or 3 SD range
can only be done if the control barcode card is scanned
before

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 11: Adding new tests to the system

Exercise 11: Adding new tests to the system

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Program the cobas e 411 analyzer for a new test
o Program a calculated test formula of the new test, if necessary
o Verify that all new settings are programmed properly by calibrating and
controlling the new test

Exercises

Configure the test application settings

o Touch Utility/Application/Range
Program the cobas e 411 o Verify the User Test number according to Host settings
analyzer for a new test o Choose the proper Unit from the field box
o Define the normal expected value ranges for the three
sample material type, if necessary
o Save all the application changes of the new test
Configure the calc. test formula
o Go to Utility/Calc. menu
Program a calculated test o The following formulas are available and can be entered:
formula of the new test, free PSA
if necessary % free PSA ratio = ----------------------- × 100
total PSA
T4-
fT4 index = --------
TB1
Testosterone
% FTI (free testosterone index) = -------------------------------- × 100
SHBSG
Perform calibration and quality control testing
o Load new calibrator vials first and then new control vials
Verify that all new settings o Pour control material for non-Roche control into a
are programmed properly by normal Hitachi sample cup and program a rack
calibrating and controlling assignment for this control
the new test Perform sample processing
o Program five samples for the new test
o Load the patient samples
o Make sure that no alarm is displayed before starting the
run
o Press Start
Perform result evaluation
o Evaluate calibration, control and samples results of the
new test

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 11: Adding new tests to the system

Quiz

Mark each of the following statements with a l if true for startup and routine
operation:

The Application screen is used to view, added and updates application parameters

The Default ratio field settings is in charge of the second measurement of a rerun

Both calibration workflow options “Timeout and QC Violation” can be used for a
test
Units can be changed only once after installation of the new test

User Test Number is important for Host and Key settings

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 12: Calibration and quality control

Exercise 12: Calibration and quality control

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Prepare calibrator and quality control materials according to packages inserts
o Perform a bar-coded calibration run

Exercises

CalSet components
o Separate calibrators are required for each tests
Prepare calibrator and quality o Two sets/levels of calibrators are packaged in each kit
control materials according to o Check the stability and storage information
packages inserts o Bring the calibrator material to room temperature before
testing
Control Set components
o Different controls belonging to several tests
o Usually, two set/Levels of controls are packaged in each
kit
o Check the stability and storage information
o Bring the control material to room temperature before
testing
o Scan process can be done in Standby mode only
o Place the calibrator bar-code card after installation and
settings of the applications
Perform a bar-coded
o Certain tests, e.g. HBsAG, Anti-TPO come with
calibration run
calibrators in the reagent kit, therefore no bar-code card
is required
o Touch the Calibrator/Install menu and select the Scan BC
card tab
o Do not remove the card until the system returns to
Standby
o Repeat it for all tests and if with new lots
o Check if all the calibrators are install correctly
(highlighted with blue color)
o Load the calibrators, with lids open, observing correct
placement of vials
o Both calibrator vials must be next to each other
o Do not split a calibrator set between two racks
o

o On the disk system, place the Stop barcode tube after the
last vial

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Exercise 13: Calibration and quality control

Exercise 13: Calibration and quality control

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Perform a bar-coded control run
o Request and print the calibration and control list

Exercises

o Scan process can be done in Standby mode only

o Place the control barcode card after installation and
settings of the applications
Perform a bar-coded control
o Touch the Control/Install menu and select the Scan BC
run
card tab
o Do not remove the card until the system returns to
Standby
o Repeat for all control materials and if a new lots is
available
o Check that all the controls are installed correctly
o Activate the test applicable to the controls
o If a non-Roche control is used, select Add button and
enter the information, target values, and standard
deviations for the applicable tests. If done afterwards,
choose Edit, then active the tests as well.
Because no bar-code labels are available for non-Roche
controls, rack assignment has to be done
o Load the controls, with lids open, observing correct
placement of vials
o Controls can be placed separately.
o

o On the disk system, place the Stop barcode tube after the
last vial
Calibration:
o Touch the Calibration/Status menu and select the test
Request and print the which should be calibrated or a calibration cause is
calibration and control list displayed and is required to calibrate
use the print view as well Control:
o Touch the Control/Status menu and select the tests which
has to be controlled
Print the list:
o Touch Global Button Print button and select the load list
for calibrator and controls
o Check the lists and troubleshoot if necessary
If vials are prepared and on board, press Start to initiate the
run

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 14: Calibration and quality control

Exercise 14: Calibration and quality control

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Evaluate control results

Exercises

o Touch Sample Tracking button from System Overview

o Check the status of the calibration and control vials
Track sample progress o
through the run

o For disk systems, check results for each sample in

positions 1 to 30 on the sample disk (multiple or single
disk use)

o For rack systems, check for each sample in the output

buffer contains five racks, each containing five sample
positions
View the calibration results from different screens:
o Sample tracking screen
Evaluate calibration results o Alarm screen, leave alarm messages until result
evaluation is finished completely
o Calibration/Status/Calibration Result menu
o Calibration/Status/Calibration Trace menu
o If a calibration has failed, troubleshoot the problem and
repeat it to the corresponding condition using the
Training Guide/Calibration menu/Calibration Quality
Criteria and Help function from the user interface
o Usually, calibration result is printed automatically after
measurement
o Usually, calibration result is printed automatically after
Print calibration result and
measurement
trace list
o Use the Print button, if printing has to be started
manually
o Print a calibration trace list as well
o Also use Print View button on the System Overview
screen

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Exercise 15: Calibration and quality control

Exercise 15: Calibration and quality control

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Evaluate control results

Exercises

View the control results from different screens:

o Sample tracking screen
Evaluate control results o Alarm screen, leave alarm messages until control result
evaluation is finished completely
o Workplace/Data Review screen
o Workplace/Data Review/Test Review screen
o Workplace/Data Filter function for controls
o Control/Run Status
o Control Individual screen and chart
o If a control gets a flag, troubleshoot the problem and
repeat it to the corresponding condition using the
Training Guide/Control menu and HELP function from
the User Interface
o Usually, calibration result is printed automatically after
measurement
o Usually, control result is printed automatically after
Print control result and
measurement
individual control chart and
o Use the Print button, if printing has to be started
list
manually.
o First select the controls from the Workplace/Data Review
which should be printed
o Print individual control chart and list too
o Use Print View button as well from the System Overview

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 15: Calibration and quality control

Quiz

Mark each of the following statements with a l if true for calibration and quality
control:

Only one calibration lot number can be installed for a test

If the Expiration column is highlighted in red, the corresponding calibrator has

expired and can not be used anymore
If the difference between the duplicate measurements of one or more calibrator level
is too high (in general > 10%), the calibration is failed (yellow)
Run Status screen is used to get an overview of the last 500 quality control (QC)
measurements or to view the most recent QC measurements for one particular test
specified
Individual QC Chart screen displays all recent values per test for each control

This icon is used for standby controls, which can be viewed under the QC chart

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Exercise 16: Addition routine tasks

Exercise 16: Addition routine tasks

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Add routine samples during run
o Add STAT samples during run
o Program a sample with an manual rerun

Exercises

Use different fields for running two samples, when the system
has started sampling:

Add routine samples during o Add two routine samples

run o Sample type serum
o Sample ID number from the barcode label
o Sample volume (dilution factor) for a test
Use different fields for running two samples:
o Press STAT rack/STAT disk button for a STAT samples
Add STAT samples during o Use STAT tab for the identification
run o Sample type serum
o Patient name
o

o For disk systems, use the Disk ID (non-barcode mode)

o For rack systems, use the Rack ID (non-barcode mode)

o Use normal sample volume
o If system is in S.Stop, press Start again
o Follow the status from the sample tracking screen
o Precondition:
>Ref flag is displayed for a sample ID
o Select the sample ID from the Sample Tracking screen or
Program a sample with an
from the Data Review screen
manual rerun
o Same sample ID is used and marked with the tab rerun
o Test is added and started once again
o Before starting, make sure that diluent for that particular
test is on board

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 17: Addition routine tasks

Exercise 17: Addition routine tasks

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Prepare control material according to package inserts
o Control all the active and standby reagent packs with are on board

Exercises

o Kits may contain one, two, or three levels of quality

controls material
o Usually, two sets of controls are packaged in each kit
Prepare control material
o Control target values and ranges are read into the system
according to package inserts
with the control card
Use two control levels with barcode labels:
o Go to the Control/Status screen
o Select the routine tests to be controlled
o Go to the Control/Status/Standby screen
o Select the standby tests to be controlled
o Print the control load list from the System Overview or
from the Print button
o Check the required volume
o

o Place the vials into a disk

o Or place the vials into a rack

o Press Start
o Follow the status from the sample tracking screen
View the control results from different screens for evaluation:
o Sample tracking screen
Review results relating to o Alarm screen, leave alarm messages until result
system alarms and data flags evaluation is finished completely
o Workplace/Data Review screen
o Workplace/Data Review/Test Review screen
o Workplace/Data Filter function
If a flag appears, troubleshoot the corresponding condition
using the Training Guide/Troubleshooting/Data Alarms and
HELP function from the User Interface

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cobas e 411 analyzer 22 Answers to laboratory exercises
Exercise 17: Addition routine tasks

Quiz

Mark each of the following statements with a l if true for additional routine tasks:

Controls are used to monitor system accuracy and reproducibility over time

Control Load list can be printed from the System Overview only

Standby reagent packs can be viewed on the graphical System Overview screen,
Reagent list, Control/Status/Standby QC bottle screen and on printing lists, Test
Review screen
Controls do not get the status P (in processing) in the sample tracking screen

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22 Answers to laboratory exercises cobas e 411 analyzer
Exercise 18: Maintenance

Exercise 18: Maintenance

Objectives

At the conclusion of this exercise, the operator should have the skills necessary to:
o Knows the schedule for all maintenance actions
o Perform the daily, weekly, and two-weekly maintenance procedures
Daily Weekly Two-weekly

Exercises

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Exercise 18: Maintenance

Match the following:

A Liquid Flow Cleaning

E Finalization maintenance

B Clean Sample/Reagent probe

D System Reset

C As needed
A Every two-week with SysClean

D Sipper needle is blocked

B Daily maintenance

E If the run is interrupted, process has to

be started manually
E Are used to verify calibration curve

Quiz

Mark each of the following statements with a l if true:

System reset does include a reset for line mechanisms on a rack system

The weekly maintenance should be done in Power Off mode

The SysWash solution is used for the “Liquid Flow Cleaning” maintenance

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Exercise 18: Maintenance

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Notes I