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What is ‘Analytical Measurement Range’ (AMR)?

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The College of American Pathologists (CAP) uses Analytical Measurement Range (AMR) as part of their checklist for their Laboratory Accreditation Program. AMR is used as part of the CAP checklists to satisfy the CLIA ’88 requirements for the term ‘calibration verification’. CAP uses two terms – calibration verification and AMR validation – to identify the two distinct processes required. Definitions from CAP are provided below. Per the article below, AMR must be revalidated at least every six months. From March 2003 CAP Today, “Analytical measurement range validation: The process of confirming that the assay system will correctly recover the concentration or activity of the analyte over the AMR. The materials used for validation must be known to have matrix characteristics appropriate for the method. The matrix of the sample – that is, the environment in which the sample is suspended or dissolved-may influence the measurement of the analyte. In many cases, the method manufacturer will ... more
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