CLSI I-LA18-A2 Immunological Test Specifications for Infectious Diseases - Approved Guideline

It addresses common issues associated with the preparation and characterization of antigens and antibodies, testing using these reagents, and understanding results. It provides specifications for reference materials as well as approved guidance on Immunological test specifications for infectious diseases, recommendations on sample collection, processing and storage, and performance criteria for comparison of immunoassay kits.

This standard addresses several issues that require particular attention, including:

• Determination of the purity and structure of antigens used as immunogens or detection molecules in tests;
• Antibody specificity and quantification (titer or other measurement);
• Use of reinforcing and enhancing agents; Interfering substances;
• Sensitivity and specificity criteria and procedures for assessing sensitivity and specificity for assays;
• patient preparation and sample collection and processing;
• Laboratory and clinical evaluation of test results;
• Specifications for reference materials;
• Storage conditions for samples and reference materials;
• Performance criteria to ensure comparability of results between methods and laboratories;
• Recommendations for product labeling and product literature, including limitations of procedures.

EUROLAB assists manufacturers with CLSI I-LA18-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.