CLSI I/LA21-A2-2008

Clinical and Laboratory Standards Institute document I/LA21-A2–Clinical Evaluation of Immunoassays; Approved Guideline–Second Edition addresses all aspects of the clinical evaluation of immunoassays developed for commercial or in-house use.

Existing CLSI documents provide guidance for assessing analytical performance, methods comparison, and clinical accuracy of laboratory tests. This document focuses on unique characteristics of immunoassays, and provides a guide to designing, executing, and analyzing a clinical evaluation. In addition, this document will aid 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.

The elements of this guideline include: 1) a development plan for an effective analysis and evaluation; 2) a discussion of the planning and design considerations that are necessary for a successful evaluation; 3) a description of requirements for conducting the evaluation through monitoring and database management; and 4) a brief review of the analytical performance measures that must be in place before testing clinical specimens.