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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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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
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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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Diagnostic target product profiles for monitoring, evaluation and surveillance of schistosomiasis control programmes

World Health Organization WHO (2021) C_WHO
Health ministries currently lack effective tools for monitoring and evaluation of schistosomiasis control programmes. Egg detection can be used, but the cost, challenges of obtaining samples, and the need for trained personnel and equipment limit the frequency of monitoring. The purpose of this TPP ... more