CLINICAL CHEMISTRY AUTOANALYZER AND QUALITY CONTROL

AUTOMATION
Definition :
The term automation has been applied in clinical chemistry to describe the
process whereby an analytical instrument performs many tests with only
minimal involvement of an analyst.
In simple terms it ismechanization of the steps of laboratory procedures. The
availability of automated instruments enables laboratories to process much
larger work- loads without comparable increases in staffs.
There are four basic approaches to automation:-
1. Continuous flow analyzers,
2. Discrete analyzers,
3. Centrifugal analyzers and
4. Dry chemicalanalyzers
1. Continuous flow analyzers :
It is an automated chemical analyzer in which the samples and
reagents are pumped continuously through a system of modules
interconnected by tubing.
It can be of 2types - single channel&multi channel .
Single Channel :
Samples and reagents are passed sequentially through the same
analytical pathway and separated by means of air bubbles.
Consists of probe , sampler , proportionating pump , dialyzer, healing
bath , colorimeter and printer.
Advantages : To test largespecimens for a particular test.
Disadvantages : only one type of test (urea / glucose ) can be done at a
time&It occupies large space.
Multi Channel :
They are sequential multiple analyzers.
Advantage : Many specimen can be run per hour ( 60 tests).
Disadvantages : It occupies large space&Now Obsolete.
 2. Discrete Analyzers :
Specific features of this analyzers are :
 Reagents and specimens are pipetted in acuvette , mixed and end
product recorded photometrically.
 All end product reaction are 2- point assays – monochromatic or
dichromatic reading.
Semi -automated Discrete analyzers :
 It is a kind of discrete analyzer which operates semi-automatically.
 Initial stages of a specimen analysis are performed by a lab technician.
 Pipetting of reagent, pipetting of specimen, mixing and incubating the
reaction mixture – by technician.
 Reading is at the end point , rate of reaction , displaying test result
printing , memorizing and graph – by machine.
Advantage of discrete analyzers:
1. Number of parameters per sample
2. lowest reagent and sample consumption
3. lower cost per analysis
4. Easy to use and maintain
5. Stable calibration
Disadvantage of discrete analyzers:
- Since each sample is in a separate reaction container , uniformity of
quality must be maintained in each cuvet so that a particular sample
quality is not affected by the cuvet it is placed in.

3. Centrifugal analyzers:
These systems uses the force generated by centrifugation to transfer
and then contain liquids in separate cuvettes for measurements. The
samples and the reagents are pipetted from their respective
cups/containers, into Teflon rotor with multiple positions (generally 20
or 30). Each position contains a sample compartment, a reagent
compartment, and a cuvette located at the periphery of the rotor. The
components are then mixed by rotating the rotor at about 100 rpm until
reaction temperature is reached, then accelerating to a speed of 4000
 rpm to transfer the samples and the reagents into the cuvettes, and
finally breaking to a complete stop to mix the reagents. The whole
process of transferring and mixing occurs in less than 3 seconds. The
reading of OD and calculation is microprocessor/computer based .
Advantage :
1. Rapid test performance analyzing multiple samples. Batch analysis is
a major advantage because reactions in all cuvets are read virtually
simultaneously .
2. Use small sample ( as small as 2µL ).
3. Use small reagent volumes (250µL).
4. Can be programmed to carry out many different assay methods.
Disadvantage:
1. Only one test type can be performed each time.
2. Each cuvet must be uniformly matched to each other to maintain quality
handling of each sample .
4. Dry chemical analyzers :
Dry chemical methods utilize reagent slides that are composed of
several layers which may include Spreading, scavenger , Reagent and
Indicator/ support layers) mounted between plastic slides. Samples
seep through the layers and interact with the reagents along the way,
finally reaching the indicator layer. Each layer along the path offers a
unique environment for the reaction to proceed optimally.
The color developed is proportional to the concentration of the analyte
in the sample. The slides placed on a station move with a preset speed
and reach the detector. Reflectance spectrophotometry is used to read
the amount of the chromogen developed in the indicator layer. The light
passes through the indicator layer, is reflected from the bottom of a
pigment-containing layer and is returned through the indicator layer to a
light detector.
Advantages :
1. Uses dry chemistry hence incurring minimum storage costs .
2. ISE (Ion selective electrode) allows a sample to be analyzed for
electrolytes separately even when the analyzer is analyzing a batch of
other of other samples for various other tests.
 Disadvantages :
1. Samples with abnormal high protein may introduce significant
errors(sample dilution may be necessary).

Batch analyzers :
 They are outdated.
 Analyzers performed only one type of test at a time.
 Only one type of reagent can be fed at a time.
 Automated dispensing of reagents and samples.
 Automated mixing and incubation of reaction mixtures.
Advantage : Large number of sample batches were tested accurately and
precisely with appropriate QC.
Disadvantages: - Not patient oriented
- Not equipped with STAT facility
- Not having random access
Random Access analyzers :
i.Random access mode : completing all tests on one sample before
proceeding to next sample. eg- RFT, LFT, Lipid profile, TFT of single person.
ii. Sample orientation mode : completing the greatest number of sample in
shortest period of time . eg- only FBS & PPBS
iii.Sequential mode : processing one type of test at a time . eg-only TFT test.
[LEFT SIDE FLOW CHART ] :
Discrete analyzers ---Semi autoanalyzer
---Fully automated -- I .Batch analyzer
-ii.Random access analyzers
GENERAL METHODOLOGY :
The individual steps of automation is called Unit Operations.
1. Specimen Identification : Identification of the sample from the
collection to reporting is very important . some of the automated
 systems include : barcoding , optical character recognition , magnetic
strip , light pens , touch screens , smart cards etc.
2. Specimen delivery : samples collected must be transported to the
laboratory for analysis. Samples are transported using courier
( obsolete) , pneumatic tube systems , mobile robots etc.
3. Specimen Preparation and Handling : sample preparation is needed
prior to analysis including separation of serum, dilution ,
centrifugation , transfer of sample , aliquoting etc,.
4. Sample loading and aspiration .
5. Sample analysis are performed using automated machine, which
includes chemical reaction phase and measurement approaches.
6. Data Acquisition and Verification : Includes signal processing , data
handling and process control. After the analysis the reports are
ported to the computer and the technician verifies the report.
7. Reporting if Results : the reporting is done by authorized personnel
and ported to HIS ( Hospital Information System ).
8. Reagent Management : Includes reagent stock handling and storage
and delivery .
INTEGRATED SYSTEM LABORATORY : It is a new type of laboratory information
system that uses real time integration and work flow control to overcome four
demerits of current laboratory system such as
1. No real time control of users
2. Limited management of work flow
3. Most analysis are human /paper driven not machine driven
4. Limited integration of information.
To overcome these drawbacks integrated laboratory system which
included laboratory information system were developed.
LABORATORY INFORMATION SYSTEM (LIS) :
Laboratory information system is part of Hospital Information System of each
patient.LISis a unidirectional flow of clinical information from data provider to
a data receiver from laboratory only for the investigation raised for each
patient.
LIS involves
1. Patient demographics
2. Test requisition
 3. Billing
4. Specimen collection : usually a temporary accession number is given
to the specimen , which is used for processing.
5. Specimen analysis
6. Test reports
7. Test interpretation
Clinical application of LIS :
Pre Analytical / : 1. Test ordering / order entry
Pre examination 2. Preparation of phlebotomy draw list
3. Phlebotomy (labels & collection time)
4. Specimen accessioning and aliquoting
5. Specimen tracking
Analytica /
Examination : 1. Manual work list
2. Instrument book list
3. Manual result entry
4. Automated results through interface
5.Patient delta check
6. Quality control
7. Result validation
8. Interfaces to lab automated systems
Post analytical/
Post examination : 1. Non-cumulative patient chart reports
2. cumulative patient chart reports
3.Immediate remote report printing
4.Electronic result inquiry
5. archival of patient records
6. Workload working
 7. Result connection
8. Billing
9.Result interfacing with other systems

Uses of automation :
1. Increase the number of tests performed by one individual in a given
time period (short turn around time ) and faster results.
2. Human factor is decreased during the mechanical and repetitive part
of an essay as labor is an expensive commodity in Medical
laboratories.
3. To minimize the variation in results from one individual to another
( for accuracy , coefficient is reduced hence the reproducibility
increases).
4. The quality of patients test results is monitored continuously for
improvement of testing process.
5. Automation eliminates the potential errors of manual analyses such
as volumetric pipetting steps , calculation of results , and
transcription of results .(human errors reduced)
6. Instruments can use very small amount of samples and reagents
subsequently allowing less blood to be drawn from each patient.
In addition , the use of small amounts of reagents decreases the cost
of consumables.
7. Better backup of lab reports of patient which helps us to find older
reports of the same individual.