Validation and verification of measurement methods in clinical diagnosis

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Date

2021

Journal Title

Journal ISSN

Volume Title

Publisher

Lviv Politechnic Publishing House

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.

Description

Keywords

Validation, Verification, Model, Measurement, Clinical diagnostics, Quality assessment

Citation

Sydorko I. Validation and verification of measurement methods in clinical diagnosis / Ihor Sydorko, Roman Baitsar, Oksana Plakhtiy // Measuring Equipment and Metrology : scientific journal. – Lviv : Lviv Politechnic Publishing House, 2021. – Volume 82, № 3. – P. 26–31. – Bibliography: 16 titles.