Quantitative Molecular Methods for Infectious Diseases; Approved Guideline
|Publication Date:||1 November 2010|
This guideline is to be used for implementation of tests for diagnostic purposes after the benefits and potential risks associated with the use of the test in clinical practice have been considered. Specimen handling and preparation; standards, calibrators, and reference materials; analytical and clinical verification/validat
This document is intended for manufacturers or laboratories that develop tests, laboratories that perform or intend to implement such tests, clinicians that use the results to diagnose or manage patients, and agencies that regulate their use.