CLSI EP7-A2 Intervention Testing in Clinical Chemistry - Approved Guideline

This standard provides background information, guidance and experimental procedures for investigating, identifying and characterizing the effects of interfering substances on clinical chemistry test results. The U.S. Food and Drug Administration (FDA) has evaluated and accepted this approved-level consensus standard for use in meeting a regulatory requirement.

This standard is intended to serve two purposes:

• Assist manufacturers and other developers of laboratory measurement procedures in characterizing the sensitivity of measurement procedures to interfering substances by presenting scientifically valid experimental designs, specifying the relevant substances and concentrations to be tested, and describing appropriate data analysis and interpretation, and to assess potential hazards and provide users with meaningful response claims;
• By defining a systematic research strategy, specifying data collection and analysis requirements, and encouraging greater collaboration between laboratory users and manufacturers, new interactions could be identified, disclosed, and eventually eliminated.

This guide has been prepared for in vitro diagnostic medical device manufacturers and clinical laboratories.

Clinical laboratories are responsible for ensuring that measurement procedures are specific enough to meet the needs of physician clients. Laboratories should also investigate inconsistent results, identify interacting substances, and provide objective feedback to manufacturers supplying analysis systems.

EUROLAB assists manufacturers with CLSI EP7-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.