Technical Guidance Series 4 (TGS–4) for WHO Prequalification – Diagnostic Assessment: Guidance on Test Method Validation for in Vitro Diagnostic Medical Devices
(2017; 26 pages)

Abstract

WHO Prequalification is coordinated through the Department of Essential Medicines and Health Products. WHO prequalification of in vitro diagnostic medical devices (IVDs) is intended to promote and facilitate access to safe, appropriate and affordable IVDs of good quality in an equitable manner. The focus is on IVDs for priority diseases and their suitability for use in resource-limited settings. WHO Prequalification undertakes a comprehensive assessment of individual IVDs through a standardized procedure that is aligned with international best regulatory practice. It also undertakes post-qualification activities for IVDs to ensure their ongoing compliance with prequalification requirements.

The purpose of test method validation is to ensure that a method consistently produces results fit or appropriate for a specific purpose. Testing must have a useful purpose and the result from the test must be shown to be meaningful and to give the expected (and appropriate) information. In order to ensure meaningful results, the test method must be validated; otherwise the measurement has little purpose and no value. By using validated test methods, a manufacturer can have confidence that claims made in respect to the quality and performance of an IVD are supported by objective evidence.

This document is intended to provide guidance on the validation of the test methods used in manufacturing of an IVD. Sometimes test methods are referred to as analytical methods but in the context of establishing the design, the development and manufacture of an IVD, “test method” is the more commonly used and a more appropriate description since not all testing is analytical. Minimal specific guidance relating to test method validation is available for IVD manufacturers despite the abundance of guidance for the analytical chemistry or pharmaceutical industries (e.g. those from Eurachem, Eurolab, ICH, WHO and FDA or for clinical laboratories compliant with ISO 15189. This document provides information on validating the test methods used by manufacturers of IVDs in their research and development (R&D), quality control and quality assurance laboratories; it must be read as an adjunct to those formal guides mentioned previously.

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