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Target product profile for readers of rapid diagnostic tests

World Health Organisation (WHO) (2023) C_WHO
Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including malaria, HIV and COVID-19. Visually interpreted RDTs, more than any other class of diagnostics, fulfil WHO’s ASSURED criteria,1 enabling their... more
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: AiDtm anti-HIV 1+2 ELISA, Number: PQDx 0006-005-00)

World Health Organization (2016) C_WHO
PQDx 0006-005-00 WHO PQDx PR February/2016, version 2.0
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Diagnosis of childhood TB - Module 2

International Union Against Tuberculosis and Lung Disease, World Health Organization (2017) C_WHO
Accessed November 2017
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: Bioelisa HIV 1+2 Ag/Ab, Number: PQDx 0183‐060‐00)

World Health Organization (2016) C_WHO
PQDx 0183‐060‐00 WHO PQ Public Report October/2016, version 5.0
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Des tests de diagnostic moléculaire de l'infection à VIH destinés à améliorer l'access à la mesure de la charge virale et au diagnostic du VIH chez le nourrisson

Organisation Mondiale de la Santé OMS (2019) C_WHO
L’expansion de la mise en œuvre des approches de suivi du traitement par la réalisation de tests de mesure de la charge virale et de tests de diagnostic chez le nourrisson sera indispensable pour garantir la qualité des soins et des traitements ainsi que le succès des programmes. Le fait de ch... more
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Information and criteria for prioritizing diagnostic tests for SARS-CoV-2 in order to address the procurement needs of health systems

OPS (2020) C_WHO
This document provides brief information answering common questions regarding COVID-19 diagnostic tests and how to prioritize them to the patients most in need.
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: DPP® HIV 1/2 Assay, WHO reference number: PQDx 0053-006-00)

World Health Organization (2016) C_WHO
PQDx 0053-006-00 WHO PQ Public Report June/2016, version 2.0
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: AlereTM HIV/Syphilis Duo, Number: PQDx 0179-012-00)

World Health Organization (2017) C_WHO
PQDx 0179-012-00 WHO PQDx Public Report June/2017, version 4.0
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WHO Prequalification of Diagnostics Programme -Public Report (Product: BD FACSPrestoTM Near-Patient CD4 Counter System, PQ number: PQDx 0197-045-00)

World Health Organization (2016) C_WHO
PQDx 0197-045-00 WHO PQDx PR March /2016, version 2.0
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Buruli ulcer disease: rethinking diagnostic technique

Jain, S.; and R. Yotsu LSU Health New Orleans (2024) CC
Poster
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: Enzygnost HIV Integral 4, WHO reference number: PQDx 0214-064-00

World Health Organization (2016) C_WHO
PQDx 0214-064-00 WHO PQDx PR April/2016, version 3.0
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Diagnostic target product profiles for trachoma surveillance
recommended

World Health Organization WHO (2024) C_WHO
Trachoma is the leading infectious cause of blindness worldwide. In April 2023, it was a public health problem in approximately 40 countries, with an estimated 116 million people at risk and 1.5 million people affected by the late blinding stage of the disease (1). About 84% of those at risk of tr... more
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: MP Diagnostics HIV Blot 2.2, Number: PQDx 0198-071-00)

World Health Organization (2016) C_WHO
PQDx 0198-071-00 WHO PQDx PR April/2016, version 2.0
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Diphtheria: NICD Recommendations for Diagnosis, Managementand Public Health Response

The National Institute For Communicable Diseases, South Africa (2018) C1
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WHO Prequalification of Diagnostics Programme - Public Report (Product: Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device), Number: PQDx 0005-005-00)

World Health Organization (2016) C_WHO
PQDx 0005-005-00 WHO PQDx PR May/2016, version 3.0
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Diagnosis and Management of Generalized Anxiety Disorder and Panic Disorder in Adults

A. Locke, N. Kirst, C.G. Shultz American Academy of Family Physicians (2015) C2
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Dual HIV/syphilis rapid diagnostic tests can be used as the first test in antenatal care

World Health Organization WHO (2019) C_WHO
Policy Brief. WHO recommends that pregnant women receive testing for HIV, syphilis and hepatitis B (HBSAg) at least once during pregnancy, preferably in the first trimester. Dual HIV/syphilis rapid diagnostic tests (RDTs) can be used as the first test for pregnant women as part of antenatal care (... more
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Namibia: National Public Health Laboratory Policy

Ministry of Health and Social Services (MOHSS) (2012) C1
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Human Leptospirosis: Guidance for diagnosis, surveillance and control

World Health Organization (2002)
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Diagnostic errors. Technical Series on Safer Primary Care

World Health Organization WHO (2016) C_WHO