Lecture 5. Automation

PRINCIPLES OF CLINICAL
CHEMISTRY AUTOMATION
AUTOMATION IN CLINICAL CHEMISTRY
¢ Themodern clinical chemistry laboratory

uses a high degree of automation.
¢ Many steps in the analytic process that

were previously performed manually can
now be performed automatically.
¢ ThisPermits the operator to focus on

tasks that cannot be readily automated
and increasing both efficiency and
capacity.
AUTOMATION IN CLINICAL CHEMISTRY
¢ The analytic process can be divided into three
major phases— preanalytic, analytic, and
postanalytic—corresponding to sample
processing, chemical analysis, and data
management, respectively.
¢ Substantial improvements have occurred in all

three areas during the past decade.
¢ The analytic phase is the most automated, and

more research and development efforts are
focusing on increasing automation of the
preanalytic and postanalytic processes.
WHY AUTOMATION?
¢ Increasethe number of tests by one
person in a given period of time
¢ Minimizethe variations in results from

one person to another
¢ Minimizeerrors found in manual analyses

– equipment variations – pipettes
¢ Use less sample and reagent for each test

TYPES OF ANALYZERS
¢ Continuous Flow
Tubing flow of reagents and patients samples
¢ Centrifugal Analyzers
Centrifuge force to mix sample and reagents
¢ Discrete
Separate testing cuvettes for each test and
sample
Random and/or irregular access
CONTINUOUS FLOW
¢ Thisfirst “AutoAnalyzer” (AA) was a
continuous-flow, single-channel,
sequential batch analyzer capable of
providing a single test result on
approximately 40 samples per hour.
¢ Analyzers with multiple channels (for

different tests), working synchronously to
produce 6 or 12 test results
simultaneously at the rate of 360 or 720
tests per hour.
CONTINUOUS FLOW
¢ In continuous flow analyzers
samples were aspirated into tubing to

introduce samples into a sample holder,
bring in reagent,
create a chemical reaction,
and then pump the chromagen solution
into a flow-through cuvett for
spectrophotometric analysis.
CONTINUOUS FLOW
• The major drawbacks that contributed to the eventual

demise of traditional continuous-flow analyzers in the
marketplace were significant carry-over problems and
wasteful use of continuously flowing reagents.
CONTINUOUS FLOW
¢ Continuous flow is also used in some

spectrophotometric instruments in which
the chemical reaction occurs in one
reaction channel and then is rinsed out
and reused for the next sample, which
may be an entirely different chemical
reaction.
CENTRIFUGAL ANALYZERS
¢ Discrete aliquots of specimens and reagents are
piptted into discrete chambers in a rotor
¢ The specimens are subsequently analyzed in

parallel by spinning the rotor and using the
resultant centrifugal force to simultaneously
transfer and mix aliquots of specimens and
reagents into radially located cuvettes.
¢ The rotary motion is then used to move the

cuvettes through the optical path of an optical
system
DISCRETE ANALYZERS
¢ Discrete
analysis is the separation of each
sample and accompanying reagents in a
separate container.
¢ Discreteanalyzers have the capability of

running multiple tests on one sample at a
time or multiple samples one test at a
time.
¢ Theyare the most popular and versatile

analyzers and have almost completely
replaced continuous-flow and centrifugal
analyzers.
DISCRETE ANALYZERS
¢ Sample reactions are kept discrete
through the use of separate reaction
cuvettes, cells, slides, or wells that are
disposed of following chemical analysis.
¢ This keeps sample and reaction carryover

to a minimum but increases the cost per
test due to disposable products.
HITACHI 902 ANALYZER
WITH AUTOMATION THERE IS STILL
SOME VERY BASIC STEPS
¢ Specimen preparation and Identification

¢ Labeling still critical
¢ Programming of instrument
¢ Laboratory personnel must perform and

observe:
Quality Assurance
Quality Control
TOTAL LABORATORY AUTOMATION
SELECTION PROCESS
¢ What is your lab’s workload like?
Discrete or large batch testing?
Single instrument or multiples?
¢ Storage of reagents
Need refrigeration or freezing? expense
Kept at room temperature until
reconstituted
QUALITY CONTROL & AUTOMATION
¢ Automated quality control is a digital technology to
improve:
- Quality inspections by reducing mistakes in the

workflow.
- Eliminating manual proofreading.
- Performance can be improved and get results faster

without compromising quality.
Standard Operating Procedures
(SOP)
• comprehensively written document that
describes the laboratory procedure and all other
related issues
• Essential for ensuring uniformity in laboratory
procedures
•The SOP should define test performance,
tolerance limits, reagent preparation, required
quality control, result reporting and references
20
• The SOPM should be written in CLSI (Clinical Laboratory
Standards Institute) format and must be reviewed and signed
annually by the Laboratory director
• Must contain all test methods performed by the laboratory

• The SOPM should be available in the work area. It is the
definitive laboratory reference and is used often for questions
relating to individual test
• Any obsolete procedures should be dated when removed from

SOPM and retained for at least 2 years
21
OUTLINE FOR A CLSI PROCEDURE
DOCUMENT
A. Title: intent of the document; concise
B. Purpose or Principle: “the process describes..” info.
regarding theory, clinical implications of examination
22
C. Procedure instruction: “how to do” a particular
steps, steps involved
D. Related Documents: listing of other procedures used
E. References: reference the source of information
F. Appendixes or attachments: additional information
G. Author(s): author of the document should be
documented
H. Approved Signature: Evidence that the document
has been approved
Validation
ü is about determining whether

something does what it is
supposed to do
23
Importance of validation
• Validation - before we introduce something
• Re-validation
– after we have changed/modified
– periodic
• Validation is applied to:
– SOP
– reagents
– equipment
– software
24
Housekeeping
• Surface decontamination of instruments, bench-tops,

biosafety hoods and general tidiness
• Disposal of biohazardous waste
• Monitoring of fridge, freezer and incubator temperatures
25
¢ http://www.youtube.com/watch?v=FyLOTBicYbk

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PRINCIPLES OF CLINICAL

¢ Themodern clinical chemistry laboratory

¢ Many steps in the analytic process that

¢ ThisPermits the operator to focus on

¢ Substantial improvements have occurred in all

¢ The analytic phase is the most automated, and

¢ Minimizethe variations in results from

¢ Minimizeerrors found in manual analyses

¢ Use less sample and reagent for each test

¢ Analyzers with multiple channels (for

 samples were aspirated into tubing to

• The major drawbacks that contributed to the eventual

¢ Continuous flow is also used in some

¢ The specimens are subsequently analyzed in

¢ The rotary motion is then used to move the

¢ Discreteanalyzers have the capability of

¢ Theyare the most popular and versatile

¢ This keeps sample and reaction carryover

¢ Specimen preparation and Identification

¢ Laboratory personnel must perform and

- Quality inspections by reducing mistakes in the

- Eliminating manual proofreading.

- Performance can be improved and get results faster

• Must contain all test methods performed by the laboratory

• Any obsolete procedures should be dated when removed from

ü is about determining whether

• Surface decontamination of instruments, bench-tops,

• Disposal of biohazardous waste

• Monitoring of fridge, freezer and incubator temperatures

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samples were aspirated into tubing to