CLINICAL LABORATORY

AUTOMATIONS
LEARNING OBJECTIVES
At the end of the discussion, students shall be able to:
❑Definition of clinical laboratory automations
❑Learn the types and the benefits of automations
❑Understand the mechanism of different automated
analyzers
❑Explain the Quality Control
I. DEFINITION

• Automation is the use of various control systems

for operating equipments and other applications
with minimum human intervention.
• The use of automation in clinical
laboratory enables to perform many tests by
analytical instruments with minimum use of an
analyst.
II. HISTORICAL BACKGROUND :
• First automated analyzer was introduced by Technicon in
1957
• It was a continuous flow, single channel , sequential batch
analyzer capable of providing a single test result on
approx. 40 samples per hour.
• Next major development occurred in 1970 with
introduction of Automatic Clinical Analyzer.
• Most recent milestone in chemistry is the development of
an analyzer having combination of chemistry and
immunoassay into a single modular analyzer.
III. TYPES OF AUTOMATION :
1. Subtotal automation (modular integrated automation)
2. Total laboratory automation
3. Stand-Alone system
4. Auto-analyzer
5. Closed automation
6. Open automation
7. Discrete analysis
8. Random access analysis
IV. BENEFITS OF AUTOMATION :
1. Effectively lowers the cost per test
2. Minimizes the variation in results
3. Coefficient of variance is reduce and reproducibility is increased.
4. Workload is decreased
5. Small amounts of samples and reagents are used decreasing the cost of
consumables.
6. Reduce turn around time
7. Increasing the quality of work
V. TOTAL LABORATORY AUTOMATION :
Total Laboratory Automation (TLA) is an automation system for the
performance of highly repetitive tasks in the Laboratory.
Laboratory automation consolidates the control of multiple different
analytical instruments to a smaller number of operators, thus reducing
the costs in laboratory testing.
• TLA is the most recent and most exciting development in Chemical
Pathology Laboratories. It consist of 3 main parts :
• Pre analytic phase (sample processing)
• Analytic phase ( chemical analysis)
• Post analytic phase (data management)
VI. IMPORTANT CONSIDERATIONS :
oEconomic and reliable operation
oReduce human resource cost
oLab space (cost of space renovations)
oUp-gradation/ menu extension
oService back up
oAvailability of on-site biomedical engineer
oStandardization of specimen tubes
VII. AUTOMATED ANALYZER :
oSpecimen identification
oSpecimen preparation
oChemical reaction
oData collection
oAnalysis
1. PRE ANALYTIC PHASE :
• The pre-analytic testing phase occurs first in the
laboratory process. This phase may include specimen
handling issues that occur even prior to the time the
specimen is received in the laboratory. Important errors
can occur during the pre-analytic phase with specimen
handling and identification.
STEPS OF PRE-ANALYSIS :
✓Specimen barcode
✓Data entry of patient
✓Transportation of specimen to specified area.
✓Loading of specimen on track
✓Centrifugation
✓Decapping
✓To the analyzer
 STEPS AUTOMATED
IN THE DIAGNOSTIC LABORATORY

Post-Analytical Pre-Analytical
prepare order
collect sample
transport to lab
Sample retrieval
accession sample
store samples

dispose of waste centrifuge

post-sort decap tubes

transmit test results pre-sort/aliquot

technical validation transport to analyzer

Analytical
2. ANALYTIC PHASE :
• The second phase is the analytic phases. This phase includes what
is usually considered the "actual" laboratory testing or the
diagnostic procedures, processes, and products that ultimately
provide results.
It includes
• Input / output module
• Tube storage module
 CONTINUOUS FLOW ANALYZER :
oAn automated chemical analyzer in which the samples and reagents
are
pumped continuously through a system of modules interconnected by
tubing.
oIt operates by introducing a sample and reagent(s) into tubing
separated by bubbles. Each segment of sample mixture goes through a
mixing coil or other tubing where chemical reactions occur. Various
modules can be introduced to perform specific chemical reactions.
oThere are significant carry-over problems and wasteful use of
continuously flowing reagents, which lead to the demise of these
analyzers.
 CONTINUOUS FLOW ANALYZER :
Advantage :
• Major use for certain test profiles (e.g. liver function, lipid function).

• Single channel machines may be used for frequently requested

independent analysis (e.g. blood glucose, blood total protein).
Disadvantages:
• The machine does not allow test selection; all tests must be performed
even if not requested.
 CENTRIFUGAL ANALYZERS :

• Discrete aliquots of specimens and reagents are pipetted

into discrete chambers in a rotor.
• Centrifugal force is used to mix specimen and reagents. The
rotary motion is then used to move the cuvettes through the
optical path of an optical system
CENTRIFUGAL ANALYZERS :
 CENTRIFUGAL ANALYZERS :
Advantage
• Rapid test performance, analysing multiple samples. Batch analysis is a
major advantage because reactions in all cuvets are read virtually
simultaneously.
• Use small sample (as small as 2μL).
• Use small reagent volumes (250μL).
Disadvantage
• Only one test type can be performed each time.
• Each cuvet must be uniformly matched to each other to maintain quality
handling of each sample
 DISCRETE ANALYZERS :
oSeparate testing cuvettes for each test and specimen.
oThey have the capability of running multiple tests on one specimen
at a time or multiple specimens testing at one time.
oMost popular analyzers and have almost completely replaced
continuous-flow and centrifugal analyzers.
oSeparate reaction cuvettes, cells, slides, or wells that are disposed of
following chemical analysis are used. This keeps specimen and
reaction carryover to a minimum but increases the cost per test due
to disposable products.
oThese analyzers are also called ‘random access’ analyzers
 DISCRETE ANALYZERS :
Advantage:
• Assay by reflectance photometry offers advantages:
• The storage requirements for reagents are minimal since no wet
reagents are required.
• No pipetting steps are needed as the manufacturing company prepares
the slides.
• No sample dilution is required and 10 or 11 μl of sample per test is used.
Disadvantages:
• Since each sample is in a separate reaction container, uniformity of
quality must be maintained in each cuvete so that a particular sample
quality is not affected by the cuvete it is placed in.
3. POST-ANALYTIC PHASE :
oThe post-analytic phase is the final phase of the
laboratory process. This phase culminates in the
production of a final value, result, or a diagnostic
pathology report.
oThe computer is connected with the software of the
equipment and report can be generated by giving order.
VIII. Four Q Model of Instrument Qualification :

oDESIGN QUALIFICATION: documentation of required specifications of

design and its function. It also documents qualification of vender or
supplier.
oINSTALLATION QUALIFICATION: documented verification that system
is installed according to written and preapproved specifications
oOPERATIONAL QUALIFICATION: includes verification that system is
operating in accordance with preapproved and written specifications
under normal and stressed conditions.
oPERFORMANCE QUALIFICATION: it includes ongoing monitoring of
performance, testing for specified application and periodic updates
about the analyzer.