Clinical Evaluation of CLSI I-LA21-A2 Immunoassays - Approved Guideline

Institute of clinical and laboratory standards document The approved guideline for the clinical evaluation of I-LA21-A2 immunoassays addresses all aspects of clinical evaluation of immunoassays developed for commercial or in-house use.

Existing CLSI documents provide guidance for evaluating the analytical performance, method comparison, and clinical accuracy of laboratory tests. This standard focuses on the unique features of immunoassays and provides a guide for designing, conducting and analyzing a clinical assessment. In addition, this standard will assist developers of "in-house" tests for institutional use, developers of tests used to monitor the pharmacological effects of new drugs or biologics, and clinical and regulatory personnel responsible for commercializing products.

Elements of this guide include:

• A development plan for effective analysis and evaluation;
• Discussing the planning and design considerations necessary for a successful evaluation;
• A description of the requirements for conducting the assessment through monitoring and database management;
• A brief review of analytical performance measures that should be applied before testing clinical samples.

EUROLAB assists manufacturers with CLSI I-LA21-A2 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.