Clinical Pathology: General Principles, Lab Management, Clinical Chemistry

• Carryover refers to the transfer of a quantity of an analyte from one reaction into the next subsequent reaction.

• Carryover of an analyte could potentially cause a false elevation in patient results and, therefore, should be assessed when validating a new test system, if applicable to the methodology.

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

• Precision is the agreement between result values obtained by repeat measurements of a quantity.

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

Centers for Medicare and Medicaid Services. Verification of Performance Specifications Brochure #2. Accessed 15 Jan 2014.

Rambla-Alegre M, Esteve-Romero J, Carda-Broch S: Is it really necessary to validate an analytical method or not? That is the question. J Chromatogr A 2012. doi:10.1016/j.chroma.2011.10.050

Araujo P: Key aspects of analytical method validation and linearity evaluation. J Chromatogr B Analyt Technol Biomed Life Sci 2009;877:2224-2234.

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