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Malaria rapid diagnostic tests, second edition: Technical specifications series for submission to WHO prequalification – diagnostic assessment

World Health Organization WHO (2025) C_WHO
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin... more
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Malaria rapid diagnostic tests, 2nd edition - Technical specifications series for submission to WHO prequalification – diagnostic assessment

World Health Organization WHO (2025) C_WHO
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin... more
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Malaria rapid diagnostic test performance. Results of WHO product testing of malaria RDTs round 8 (2016-2018). Summary

World Health Organization WHO; FIND; CDC (2018) C_WHO
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 diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distingui... more
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Malaria Rapid Diagnostic Test Performance. Summary results of WHO product testing of malaria RDTs: round 1 -7 (2008 –2016)

E. Heseltine World Health Organisation (WHO) (2017) C_WHO
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Malaria Rapid Diagnostic Tests - Technical Bulletin November 2024

UNICEF (2024) C_WHO
Malaria remains a significant global health concern, with 249 million cases and 408,000 deaths reported in 2022, primarily in sub-Saharan Africa. The most vulnerable populations are children under five and pregnant women. Rapid and accurate diagnosis using microscopy or malaria rapid diagnostic test... more
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Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19
recommended

African Union; Africa CDC Centres for Disease Control and Prevention; AMREF; ASLM; et al. (2021) CC
ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to pr... more
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WHO standard: universal access to rapid tuberculosis diagnostics

World Health Organisation (WHO) (2023) C_WHO
The WHO standard: Universal access to rapid tuberculosis diagnostics sets benchmarks to achieve universal access to WHO-recommended rapid diagnostics (WRDs), increase bacteriologically confirmed tuberculosis and drug resistance detection, and reduce the time to diagnosis. WHO-recommended rapid diagn... more
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Rapid communication: TB antigen-based skin tests for the diagnosis of TB infection

World Health Organization WHO (2022) C_WHO
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Molecular assays intended as initial tests for the diagnosis of pulmonary and extrapulmonary TB and rifampicin resistance in adults and children: rapid communication

World Health Organization WHO (2020) C_WHO
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Cadre de l'Assurance Qualité Test de Diagnostic Rapide de l'Antigene COV-2-SARS
recommended

African Union; Africa CDC Centres for Disease Control and Prevention; AMREF; ASLM; et al. (2021) CC
ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to pr... more
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Rapid Communication: Molecular assays as initial tests for the diagnosis of tuberculosis and rifampicin resistance

World Health Organization WHO (2020) C_WHO
This Rapid Communication aims to inform national TB programmes and other stakeholders about the key implications of the latest evidence on the use of specific molecular assays as initial diagnostic tests of pulmonary and extrapulmonary TB and RR-TB, in adults and children.
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LIST OF RAPID DIAGNOSTIC TEST (RDT) KITS FOR MALARIA classified according to the Global Fund Quality Assurance Policy

THE GLOBAL FUND (2025) C_WHO
This document provides an overview of malaria rapid diagnostic tests (RDTs) for Principal Recipients (PRs) of Global Fund grants, indicating their eligibility for procurement under the Global Fund's Quality Assurance Policy. The included products have been assessed and approved by the WHO Prequalifi... more
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Market and technology landscape x HIV rapid diagnostic tests for self-testing - 4th edition (Supplement)

Unitaid (Innovation in Global Health), World Health Organization (WHO) Unitaid (Innovation in Global Health), World Health Organization (WHO) (2018) C2
July 2018
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Target product profile for a rapid test for diagnosis of Buruli ulcer at the primary health-care level

World Health Organization WHO (2022) C_WHO
In 2009, WHO’s Second International Conference on Buruli Ulcer Control and Research resolved to strengthen the capacity of national laboratories to confirm cases of the disease, but advised that “efforts are still needed to develop simple diagnostic tools usable in the field as well as disabilit... more
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Market and technology landscape HIV rapid diagnostic tests for self-testing - 4th Edition

O. Ajose; C. Pérez Casas; H. Ingold; et al. Unitaid (Innovation in Global Health); World Health Organization (WHO) (2018) C2
July 2018
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SARS-CoV-2 antigen rapid diagnostic testing. Online Course
recommended

World Health Organization WHO (2021) C_WHO
All personnel performing SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDT) need to understand how to safely perform testing, ensure quality testing and interpret results. This course is developed to provide theoretical knowledge on SARS-CoV-2 Ag-RDT testing. The learning package consists of 10 modu... more