Human Immunodeficiency Virus (HIV) rapid diagnostic tests for professional use and/or self-testing

Download or read book Human Immunodeficiency Virus (HIV) rapid diagnostic tests for professional use and/or self-testing written by and published by World Health Organization. This book was released on 2021-06-08 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 those in which 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.