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Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK

European Centre for Disease Prevention and Control ECDC (2020) C_CDC
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Second WHO Model List of Essential In Vitro Diagnostics

World Health Organization WHO (2019) C_WHO
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 intended for the detection, diagnosis and monitoring of specific diseases. The List is divid... more
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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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Especificacoes technicas para selecao de testes diagnosticos in vitro essenciais para SARS-COV-2

Organización Mundial de la Salud OMS OPAS (2021) C_WHO
TECHNICAL SPECIFICATIONS FOR TEST SELECTION ESSENTIAL IN VITRO DIAGNOSTIC TESTS FOR SARS-COV-2
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Especificacoes tecnicas para selecao de testes diagnosticos in vitro essenciais para SARS-COV-2, 14 de junho de 2021

Organização Mundial da Saúde (OMS) OPAS (2021) C_WHO
Technical specifications for selection of essential in vitro diagnostic tests for SARS-COV-2, 14 June 2021
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Angezeigte Tests zum neuartigen Coronavirus (SARS-CoV-2) in Deutschland
recommended

Bundesinstitut für Arzneimittel und Medizinprodukte (2020) CC
Tests zur Detektion einer Infektion mit SARS-CoV-2 (neuartiges Coronavirus) sowie zum Nachweis von Antikörpern gehören zu den sog. In-vitro-Diagnostika (IVD). Das erstmalige Inverkehrbringen von In-vitro-Diagnostika auf dem deutschen Markt ist nach §§ 25 und 30 Medizinproduktegesetz (MPG) anzeig... more
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Interferon-γ-Tests in der Tuberkulose-Diagnostik - Aktueller Stand

B. Hauer, R. Loddenkemper, A. Detjen, et al. (2006) C2
Interferon-γ Assays - Description and Assessment of a New Tool in the Diagnosis of Tuberculosis. Haür B et al. Interferon-γ-Tests in der ...Pneumologie 2006; 60: 29-44
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: First Response® HIV 1-2-0 Card Test, Number: PQDx 0018-010-00)

World Health Organization (2016) C_WHO
PQDx 0018-010-00 WHO PQDx PR July/2016, version 3.0
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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: 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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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: GeeniusTM HIV 1/2 Confirmatory Assay with GeeniusTM HIV 1/2 Confirmatory Controls, WHO reference number: PQDx 0181-031-00)

World Health Organization (2017) C_WHO
PQDx 0181-031-00 WHO PQ Public Report March/2017, version 3.0
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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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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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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: OraQuick HIV 1/2 Rapid Antibody Test, WHO reference number: PQDx 0159-055-00)

World Health Organization (2017) C_WHO
PQDx 0159-055-00 WHO PQ Public Report February/2017, version 5.0
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: Murex HIV Ag/Ab Combination, Number: PQDx 0144-043-00)

World Health Organization (2016) C_WHO
PQDx 0144-043-00 WHO PQDx Public Report November/2016, version 4.0
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Selection and use of Ebola in vitro diagnostic (IVD) assays. Emergency guidance

World Health Organization (2015)
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Prevention of mother-to-child transmission of hepatitis B virus: Guidelines on antiviral prophylaxis in pregnancy

World Health Organization WHO (2020) C_WHO
These guidelines provide evidence-based guidance on the use of peripartum antiviral prophylaxis in HBsAg-positive pregnant women for the prevention of mother-to-child transmission of HBV.
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Predictive values of Ebola RDTs and implications for decision-makers

World Health Organization (WHO) (2015) C_WHO
Annex to Selection and use of Ebola in vitro diagnostic assays