Technical Specifications Series 1 (TSS–1) for WHO Prequalification – Diagnostic Assessment: Human immunodeficiency virus (HIV) rapid diagnostic tests for professional use and/or self-testing. WHO Expert Committee on Biological Standardization, Sixty-eighth Report; WHO Technical Report Series No. 1011, 2018, Annex 4
(2018; 34 pages)

Abstract

The purpose of this document is to provide technical guidance to in vitro diagnostic medical device (IVD) manufacturers that intend to seek WHO prequalification of rapid diagnostic tests (RDTs) for the detection of human immunodeficiency virus (HIV). The minimum performance requirements for WHO prequalification are summarized in this document, and apply equally to RDTs intended solely for HIV detection and to those tests where HIV detection is one component of a multi-detection assay (for example, an HIV/syphilis dual-detection RDT). This document applies to RDTs intended to be used as an aid to diagnosis of HIV infection. The current version of this document does not address IVDs that discriminate between the detection of HIV-1 and HIV-2 infection, IVDs intended as confirmatory tests, or the requirements for accompanying quality control materials.

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