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Molecular Diagnostic Assay Validation Update to the 2009 AMP Molecular Diagnostic Assay Validation White Paper Members of the 2013 and 2014 Clinical Practice Committees of the Association for Molecular

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What is molecular diagnostic assay validation?

Molecular diagnostic assay validation is the process of confirming the accuracy and reliability of a diagnostic test that detects specific genetic or molecular markers.

Who is required to file molecular diagnostic assay validation?

Laboratories and healthcare facilities that perform molecular diagnostic assays are required to file validation reports.

How to fill out molecular diagnostic assay validation?

Molecular diagnostic assay validation reports can be filled out by providing detailed information about the test procedure, validation methods, and results.

What is the purpose of molecular diagnostic assay validation?

The purpose of molecular diagnostic assay validation is to ensure that the test is accurate, reliable, and produces consistent results.

What information must be reported on molecular diagnostic assay validation?

Validation reports must include information on the test's specificity, sensitivity, accuracy, precision, and reproducibility.

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