Technical Guidance Series 3 (TGS–3) for WHO Prequalification – Diagnostic Assessment: Principles of Performance Studies
(2017; 29 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 this technical guidance document is to identify the key principles that apply when conducting and reporting the study design, results and conclusion of analytical and clinical performance studies that support performance claims for in vitro diagnostic medical devices (IVDs) undergoing assessment for WHO prequalification. The document then summarizes the principles that generally apply to most performance studies. The elements discussed here support recommendations from international regulatory harmonization groups including the International Medical Device Regulators Forum (IMDRF; previously the Global Harmonization Task Force, GHTF), and the Asian Harmonization Working Party. They are consistent with the requirements of mature regulatory authorities such as the US Food and Drug Administration (FDA), the European Union and Health Canada; they are also consistent with the requirements of standards setting bodies such as the International Organization for Standardization (ISO) and the Clinical and Laboratory Standards Institute (CLSI). In addition, this document mirrors approaches taken by the Standards for Reporting Diagnostic Accuracy Studies initiative (STARD), which is a checklist of essential elements for the design and reporting of diagnostic evaluations. STARD was created because of concerns about the poor quality of design and reporting of clinical performance studies in the literature, and it has been adopted by journals as a reporting standard. This WHO document also draws on the FDA document Statistical guidance on reporting results from studies evaluating diagnostic tests.

 
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