Clinical Pathology: General Principles, Lab Management, Clinical Chemistry

• Accuracy can be assessed by measuring an analyte in reference material and comparing the result with the known certified concentration.

• Accuracy can also be assessed by comparing the test results from one method with the results from a reference method, using the same samples.

• The analytical range of an assay refers to the interval between the highest and lowest concentrations of the analyte in which precision, accuracy, and linearity have been demonstrated to be acceptable.

• The limit of detection is the lowest concentration of an analyte that can be reliably detected.

Centers for Medicare and Medicaid Services. Verification of Performance Specifications Brochure #2. Accessed 15 Jan 2014. https://www.cms.gov/CLIA/downloads/6064bk.pdf

Feinberg M: Validation of analytical methods based on accuracy profiles. J Chromatogr A 2007;1158:174-183.

 
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