CLSI EP5-A3 Evaluation of Precision of Quantitative Measurement Procedures - Approved Guideline

This standard provides guidance for studies to determine the in-house precision performance characteristics of quantitative measurement procedures used in clinical laboratories, as well as for studies addressing site-to-site verifiability. Multiple experimental protocols are described, along with considerations on how to select and optimize the most appropriate protocols for a particular measurement procedure and its intended use.

Target users of this standard are:

• Developers of a new measurement procedure who want to specify precision characteristics, whether it's a manufacturer looking to distribute the product across multiple labs, or a clinical lab that develops it for their own use;
• End users who change an existing test and therefore need to re-evaluate its precision performance;
• Users who want to understand how precision performance estimates are generated or who want to make their own rigorous precision assessments;
• Manufacturers who need advanced methods to gain deeper insights into the precision characteristics of a quantitative measurement procedure during test development, optimization and routine production;

It is assumed that readers of this standard are somewhat familiar with statistical data analysis, including basic analysis of variance or access to statistical support resources.

EUROLAB assists manufacturers with CLSI EP5-A3 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.