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Principles of Clinical Chemistry Automation. Automation In Clinical Chemistry. The modern 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.
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Automation In Clinical Chemistry • The modern 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. • This Permits 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? • Increase the number of tests by one person in a given period of time • Minimize the variations in results from one person to another • Minimize errors 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 analyzer • Discrete • Separate testing cuvets for each test and sample • Random and/or irregular access
Continuous Flow • This first “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 cuvette 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.
Discrete analyzers • Discrete analysis is the separation of each sample and accompanying reagents in a separate container. • Discrete analyzers have the capability of running multiple tests on one sample at a time or multiple samples one test at a time. • They are 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.
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
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
Definition • Point-of-care testing (POCT) has been defined by the College of American Pathologists (CAP) as “those analytical patient-testing activities provided within the institution, but performed outside the physical facilities of the clinical laboratories.”
Place of analysis • Physician’s offices • Operating rooms • Emergency rooms • Intensive Care Units • Home health care • Patient performed
Personnel Issues • Most often performed by non-laboratorians • Physicians • Nurses or nurses aides • Respiratory technicians • Not specifically trained in the requirements for accurate testing and interpretation
Laboratory Support • Laboratory still responsible for results • Therefore responsible for training and management of POCT programs • Laboratory must build a structure to support and facilitate POCT
Support Staff • Director - PhD, MD or laboratory scientist or pathologist • POC Coordinator – laboratory scientist with high level technical & interpersonal skills • POC Trainers – designated person(s) for problem solving etc.
Common Applications • Glucose Testing • Chemistries • Electrolytes • Blood gases • Hematology • Coagulation – ACT • Hematocrit