CLSI I/LA21-A2 – Clinical Evaluation of Immunoassays; Approved Guideline–Second Edition, ILA21A2E

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 oflaboratory 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 personnelresponsible for commercializing products.

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