Validation and verification of measurement methods in clinical diagnosis

Abstract

The article investigates and analyzes the validation and verification of measurement methods in the clinical diagnostic laboratory. The content and features of validation and verification are revealed. Measurement methods are considered in detail. Each direction of validation and verification of measurement methods is analyzed. The difference between validation and verification is substantiated. Measuring systems are increasingly used in the laboratories of the clinical sector. This means that the responsibility for validation lies mainly with the manufacturer. The laboratory may operate a validated methodology, which, for example, is published as a standard, or purchase a ready-made measuring system from a manufacturer for a specific application. In both cases, the main validation operate has already been done, but the laboratory must still confirm its ability to apply the method.