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This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices ... more
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices ... more
Technical specifications for selection of essential in vitro diagnostic tests for SARS-COV-2, 14 ... more
TECHNICAL SPECIFICATIONS FOR TEST SELECTION ESSENTIAL IN VITRO DIAGNOSTIC TESTS FOR SARS-COV-2
This document provides brief information answering common questions regarding COVID-19 diagnostic tests and how to prioritize them to the patients most in ... more

Market and technology landscape HIV rapid diagnostic tests for self-testing

O. Ajose; C. Pérez Casas; H. Ingold; et al. Unitaid (Innovation in Global Health); World Health Organization (WHO) (2018) C2
4th edition
The updated List of Essential Diagnostics contains 46 general tests that can be used for routine patient care as well as for the detection and diagnosis of a wide array of disease conditions, and 69 tests ... more
Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the ... more
The Interim Guidance on Cholera Rapid Diagnostic Tests (RDTs) by the Global Task Force on Cholera Control (GTFCC) provides recommendations for using RDTs to detect cholera ... more
This WHO information note provides an updated list of recommended criteria for selecting RDTs for malaria, and highlights the performance of RDTs evaluated by the WHO malaria RDT product testing programme. It also provides an overview of additional considerations ... more
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid ... more
Interim guidance, 6 October 2021 Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic ... more
The WHO Cholera Rapid Diagnostic Test (RDT) Target Product Profile outlines the key requirements for developing improved cholera RDTs. It highlights the need for fast, accurate, and easy-to-use tests ... more
Interium guidance, 25 June 2021Timely and accurate diagnostic testing is an essential tool in preventing and controlling the spread of COVID-19. This document describes recommendations for national ... more
The purpose of this TPP is to communicate the minimum and ideal characteristics desired to meet the need for discriminating low levels of risk for transmission, i.e. targeted prevalence thresholds in the surveyed areas. An ... more
This policy guideIine is intended for use by healthcare professionals invoIved in the management of Covid-19 in South Africa. The document provides guidance on ... more
Annex to Selection and use of Ebola in vitro diagnostic assays
Qualitative assay for use on the cobas®6800/8800 Systems. For in vitro diagnostic use
The recommendations in these guidelines promote the use of simple, non-invasive diagnostic tests to assess the stage of liver disease and eligibili ... more