Real-Time PCR Detection System User Manual
Real-Time PCR Detection System User Manual
User Manual
(For X960A/X960B)
Contents
Introduction
P3 How to use this manual
This manual is intended to solve your any question and technical problem in installation,
operation and maintenance of this equipment, and provides instructions on proper
installation, use and maintenance of this instrument.
Safety Cautions
Before installation, use and maintenance of this instrument, read and observe any cautions
and considerations in this guide to ensure normal operation of the equipment and user's
personal and property safety.
Instructions on Safety and Use
Operation Safety
● The power supply for this instrument must be earthed reliably. A three-pole
plug is provided for this instrument, with the additional pole connected to
earthing wire, which shall be used with an earthed power socket. Before
connecting power supply, ensure it meets the voltage requirement for this
instrument, and make sure rated load of the power socket is not lower than
the load requirement for this instrument.
● In case of any damage to the power cable, replace it with a new one of the
same model and specification. No object shall be placed onto the power
cable. The cable shall not be located at area subject to busy traffic of persons.
Connect/disconnect the power cable by holding the plug rather than any
portion of the cable itself.
Maintenance Safety
is recommended to clean the instrument with clean soft cloth soaked with
absolute alcohol. Do not use any corrosive detergent or make any detergent
enter the instrument to prevent any damage to it.
● Immediately switch off the power supply, stop test and contact your supplier
damaged.
operation.
Place the packing case upright in horizontal position, cut off the packing strip around the
case and the adhesive tape sealing the case.
Take out the accessories of the case and store them in a secure place for future use.
Remove EPE foam covered on the instrument, and lift it up by supporting its bottom with
two persons, and then locate it on a proper lab desk. Handle the instrument with caution.
which there shall not be any vibration, EMI or any high-inductance equipment (e.g.
refrigerator, centrifuge, and stirrer).
Installation of Instrument
Do not touch the power cable with wet hand. Do not disconnect the cable
during operation of the instrument. In case of any damage in the power cable, replace
it with an acceptable one. The instrument shall be always connected to a socket
earthed properly. When the power supply is disconnected, connect one end of the
network cable provided to the LAN port at the back of the instrument and the other
end to the LAN port on a PC.
Do not connect power supply until the instrument has been connected to a
PC network cable.
Connection of Instrument
Overview
① Knob ② Lid ③ Handle ④ USB Port ⑤ Pad Tray ⑥ Operation Indicator LED
⑦ Power Switch ⑧ Power Socket & Fuse ⑨ Air Outlet ⑩ 232 Interface ⑪ LAN Port
⑫ WAN Port ⑬ Air Outlet ⑭ Foot Pad ⑮ Air Inlet
Construction & Function
The lid is operated with a sliding guide to a
range as customized by the user. As shown in
the figure at the right side, you switch the knob
to the point UNLOCK and slide the lid
backwards to load the test tube into the
instrument, and then close the lid by sliding it
forwards and switch the knob to a proper
position to run the program for testing.
The handle provided on the instrument is intended for push/pull. Do not lift up or press
down the handler with force to prevent damage to the lid structure.
Do not slide lid component forwards/backwards when the mark aligns with LOCK to
prevent damage to the lid.
Turn pad tray down clockwise to a
position at an angle of 90° to the
enclosure to open the tray, and then
place a pad on the tray.
For this instrument, the tray moves in a range between 0°~90° to the enclosure; do not
move the tray out of this range to prevent damage to the instrument.
There is a status indicator LED under the front panel, which turns on in any of three colors - blue,
green, and red, respectively indicating Standby, Operating, and Alarm.
To ensure a safe and reliable testing procedure, place this instrument on a flat platform,
and reserve areas of at least 30cm wide
around the four sides of it, so as to make
sure proper ventilation and heat
dissipation.
Do not place any object at any of the air outlets to prevent overheating and
thereby permanent damage to the instrument resulted from poor ventilation.
Instrument Description
[Product Name]
Real-time fluorescence quantitative PCR unit
[Product Model]
X960A
X960B
[Construction]
It consists of power module, control module, driver module, display module,
heated lid module, sample base module, camera module, light source module, and
optical fiber module.
[Application Range]
It is applicable to polymerase chain reaction (PCR).
Instrument Performance Indicators
Product Name: Real-Time Fluorescence Dosing PCR Unit
Minimum Testing
Single copy Single copy
Template:
Reaction Volume: 15μl-100μl 15μl-100μl
Fluorescence Excitation
470nm-525nm 470nm-612nm
Wavelength:
Fluorescence Detection
525mm-571mm 525nm-678nm
Wavelength:
Installation Instructions
Preparations
Items to be prepared: instrument, PC, and connecting wires
Installation Environment
Note: A genuine edition of windows XP/VISTA/7/10 shall be used, or
otherwise any compatibility error may occur. Shut down any anti-
virus software running in the computer during installation to prevent
any false alarm (which shall be ignored if occurring). Shut down any
firewall installed in the computer.
Installation Considerations
Before Start
Note: Before installation of the software, set your computer properly to
prevent interruption of test and thereby data loss.
Single click
7. Select "None" from the drop down list in the dialog box.
Start Installation
language.
instructions.
shortcut on desktop.
installation
connection.
If the instrument connection fails, check whether it has been properly connected to the computer;
if yes, shut down any anti-virus software and restart the instrument, and then try connection after it beeps. If
connection fails again, contact the dealer for a solution.
Overview of User Interface
Interface Overview
Toolbar - File:
Load Test: Load a finished test file for display and analysis.
Import Standard Curve: Import a standard curve with similar circumstance for analysis.
Patient Information: Import patient information for printing and data analysis.
Toolbar - Control:
Disconnect: Disconnect the program from the instrument
Connect: Manually connect the program to the instrument by entering its IP address (the default is
"192.168.1.6”").
Pause: Pause operation of the project, which will be resumed in 5 minutes if no operation has been
performed.
Operate:
Toolbar - Interface:
Monitor: Switch to real-time monitoring page.
Analyze: Switch to subsequent analysis page (note: this makes sense only after a test file has been
loaded).
Toolbar - Project:
Change parameters: After a test has been loaded, when current settings are not proper to the
expectation, they may be changed under this option. Any change will be applied immediately after
completion. Change to parameters makes sense only after a test has been loaded.
Toolbar - Utilities:
TM calculator: Call a TM calculator
Toolbar - Help:
Instructions: Open instructions in the program
Project Wizard Interface:
Project Management: Open a project list and manage any project in it, and operate or modify a
project.
Open Test File: Open a test file list and manage any test file, and load or delete a file.
Instrument List: Open an instrument list, and connect or rename any instrument in it.
Creator: Specify a creator for the project, and save it by pressing ENTER. This option can be left
blank.
Reviewer: Specify a reviewer for the project, and save it by pressing ENTER. This option can be
left blank.
Test Result Path: The path where the test result is saved.
Project File Path: The path where the project file is saved.
General Settings: Call general setting page to perform some basic settings.
New Project - Sample Settings
Export: Export any sample information edited already for test next time.
Standard: Mark a certain hole position as Standard for a known concentration. This option
should be used along with sample concentration.
Gap: Gap comparison type, where water is generally used for comparison.
Standard Sample: Identify standard sample in contrast group for current test
Operate: Operate any project file saved when the instrument is connected and idle.
Analysis Interface
Introduction
It is used for analysis of test result after completion of test, including baseline setting,
analysis. .
Section V - Test Introduction and
Description
connect it to a PC by cabled or
toolbar.
New Project File
Temperature variation: Increase temperature variation for each cycle, which will be reflected to
the point in each cycle.
Gradient Width: Modular gradient can be used, and the whole module temperature will be
distributed in gradient.
Time Variation: Increase time variation for each cycle, which will be reflected to the point in each
cycle.
Collect Fluorescence: Mark it to collect fluorescence at current temperature point. Only one
temperature point can be specified for each test. Set it by referring to related agent instructions.
Add at the end: Check it to add the temperature point to the end of the program.
Created or changed temperature control
program. The small blue point indicates
the fluorescence strength in the agent
finally collected at current temperature
point.
control program
project.
Specific Test Procedure
Locate reagent
Specificity: Quantitative PCR features both primer and probe, so is more special than
conventional PCR.
Sensitivity: Sensitivity of fluorescence PCR is up to 10² copies/ml, and the range of linearity in
clinical specimen is 0~1010/copy, within which quantitative PCR will dose accurately and the
Repeatability: Quantitative PCR presents a stable result, since the threshold value is set in
relative stable, free of side effect, and the logarithm of CT and fluorescence signal are in a
linear relationship. Compared to Endpoint Method CT value is more stable and more
Safety: Without post-PCR operation steps, it reduces risk of pollution by the products.
Running Program
A project file can be run by either of
two ways:
Baseline
Baseline is a straight line along which fluorescence signals vary slightly in the first
several cycles of PCR amplification reactions.
of a certain type.
In this table you can view CT
and TM values of a certain curve
and other result information.
CT Value
Means the cycles which fluorescence signals in each PCR reaction tube undergo to
reach the Threshold value as set. According to a research, CT value of each template
is in a linear relation to the logarithm of initial copies of this template. The more
initial copies, the fewer CT value, vice versa. A standard curve can be created by
using a standard product in known initial copies, where the abscissa represents
logarithm of initial copies, and the ordinate indicates CT value. Therefore, initial
copies for an unknown sample can be calculated from the standard curve only by
determining CT value of the sample.
factor × 50/1000
Relative Quantitative Analysis - Analysis Method: 2 Ct As the most classic relative
quantitative analysis, it is mostly used in release of test report or result. Relative
quantitative analysis is available when gene and sample names are specified in test
analysis and housekeeping gene and standard samples have been set.
housekeeping gene and standard samples need to be marked. In lab test, this
Where error analysis is required, each gene and sample need to be re-tested
whether primer dimer which is not concerns of the test is produced in test.
Instructions on Amplification Curve
phase. Parallel amplification curve as a whole, flat baseline without rise, and
Standard flat and straight baseline or with slight descent, but without obvious
rise trend.
Test Considerations
● Rules and regulations issued by the authorities shall be complied with by the
laboratory.
tube, self-removing pipette and suction head with filter element shall be used.
● Prepare and handle reaction fluid in such way to avoid generation of air bubble;
check whether reaction tube is sealed tightly prior to startup to prevent leakage
● During loading sample soak the sample entirely into the reaction fluid and
prevent attachment of any sample onto the tube wall; seal the tube after loading.
● Take the reaction tube out immediately after completion of amplification, and
seal it in dedicated plastic bag and keep the bag at specified location for
● The test platform and all test appliances shall be disinfected with sodium
● PCR reaction mixed liquor shall be stored at low temperature and protected from
sunlight.
contamination.
Section VI - Other Function
Introduction
Click on "TM" from main menu to access TM Calculation page. Enter a value
and then click on "Calculate" to output the result.
The program is furnished with an embedded TM value calculator for user's access
when necessary.
Logs Recording and Retrieval
About Logs
Click on "Logs" from the main menu to access Logs page and view test operation
logs.
Facilitate management of test history records by user and retrieval of related test
history records.
Other Internal Operational Functions
loaded data.
Telephone: (0571)89905515
Email:shanghai@healforce.com
Web: www.healforce.com
20183220447
20120017
ZL 2017 1 0201257.7
ZL 2017 3 0100120.3
ZL 2017 2 0327476.5