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About Update To The 2009 AMP Molecular Diagnostic Assay Validation White Paper
CLIA (42 CFR 493.1253) and CAP (MOL 30785-31705) require laboratories to validate tests before reporting patient results. This document provides guidance on validating molecular diagnostic assays, including definitions of assay validation and verification. It describes requirements for unmodified FDA-approved tests, modified FDA-approved tests, and laboratory developed tests. Key steps in the validation process include assay design, analytical validation of accuracy, precision, and clinical validation of clinical validity and utility.
Detailed Information
| Author: | ['Huỳnh Châu'] |
|---|---|
| Publication Year: | 2019 |
| Pages: | 11 |
| Language: | English |
| Format: | |
| Price: | FREE |
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