scope:

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/validation; reporting and interpreting results; and QC and clinical utility are the focus of this document. This document does not establish a clinically acceptable limit of quantification (LoQ) because consensus for most assays is currently lacking on this issue.

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.