scope:

This document provides specific recommendations for the clinical evaluation of new immunoassays and new applications of existing assays, as well as multiple assay formats and their uses. It focuses on unique characteristics of immunoassays, and provides a guide to designing, executing, and analyzing a clinical evaluation.

The intended users of this guideline are developers of "in-house" assays for institutional use, developers of assays used for monitoring pharmacologic effects of new drugs or biologics, and clinical and regulatory personnel responsible for commercializing products.