Introducing sample, adding reagent, mixing Analytical reagent and sample, incubating, detecting, calculating, and reporting read out or results are included during which stage? Which of these tasks may be automated on All or some of the tasks various immunoassay analyzers? Reagent used in automated immunoassay Handling, preparing and storing, and dispensing analyzers requires consideration of what factors? Some reagents come ready for use, but if Properly dilute not, the analyzer must be able to do what to reagents before they can be used? What do most reagents come with that is Bar read by the analyzer to reduce operator so if the wrong reagent is loaded into the analyzer by mistake, the analyzer will detect the error and generate an error message? After reagents have been added to the Reliable results samples, the next concern is proper mixing to obtain what? Magnetic stirring, rotation paddles, forceful Mixing dispensing, and vigorous lateral shaking are all analyzers use of which method? Whichever method is used, what is That there be no splashing imperative to not do between sample wells to prevent erroneous results? incubation is then carried out at what Ambient temperatures temperatures, or analyzers need to have built-in incubators for incubation? What does the detection of the final analyte The chemistry involved in the immunoassay depend on? In addition to fluorescence or Colorimetric absorption spectroscopy chemiluminescence, both of which require fluorescence detectors, what other method can be used? Regardless of the instrumentation Proper validation of new instrumentation or methodology considered, what must always be performed? The laboratory must determine how it will Clinical Laboratory Improvement Amendment (CLIA) meet which standard regulations for verifying the manufacturer’s performance specifications? As designated by CLIA, what are the Accuracy, precision, analytic sensitivity, analytic required verifications to be determined for a specificity, interfering substances, reportable range, and new method? reference intervals What validation method is referred to as the Accuracy test’s ability to actually measure what it claims to measure?
Introducing sample, adding reagent, mixing reagent and sample, incubating, detecting, calculating, and reporting read out or results are included during which stage? Analytical Which of these tasks may be automated on various immunoassay analyzers? All or some of the tasks Reagent used in automated immunoassay analyzers requires consideration of what factors? Handling, preparing and storing, and dispensing Some reagents come ready for use, but if not, the analyzer must be able to do what to reagents before they can be used? Properly dilute What do most reagents come with that is read by the analyzer to reduce operator so if the wrong reagent is loaded into the analyzer by mistake, the analyzer will detect the error and generate an error message? Bar After reagents have been added to the samples, the next concern is proper mixing to obtain what? Reliable results Magnetic stirring, rotation paddles, forceful dispensing, and vigorous lateral shaking are all analyzers use of which method? Mixing Whichever method is used, what is imperative to not do between sample wells to prevent erroneous results? That there be no splashing incubation is then carried out at what temperatures, or analyzers need to have built-in incubators for incubation? Ambient temperatures What does the detection of the final analyte depend on? The chemistry involved in the immunoassay In addition to fluorescence or chemiluminescence, both of which require fluorescence detectors, what other method can be used? Colorimetric absorption spectroscopy Regardless of the instrumentation considered, what must always be performed? Proper validation of new instrumentation or methodology The laboratory must determine how it will meet which standard regulations for verifying the manufacturer’s performance specifications? Clinical Laboratory Improvement Amendment (CLIA) As designated by CLIA, what are the required verifications to be determined for a new method? Accuracy, precision, analytic sensitivity, analytic specificity, interfering substances, reportable range, and reference intervals What validation method is referred to as the test’s ability to actually measure what it claims to measure? Accuracy
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