Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV.
Das BfArM bietet eine Liste von
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Antigen-Tests zum direkten Erregernachweis des Coronavirus SARS-CoV-2 an. In dieser Liste befinden sich diejenigen Tests, die sich laut Herstellerangaben gemäß den Vorgaben des Medizinproduktegesetzes (MPG) rechtmäßig in Europa bzw. Deutschland in Verkehr befinden und alle vom Paul-Ehrlich-Institut in Abstimmung mit dem Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen.
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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 distingu
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ish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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This guide provides an overview of the major elements that must be considered before, during and after the implementation of antigen-detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2. This guide is complementary to policy guidance issued by
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the World Health Organization (WHO). The guide may appeal to a range of audiences including Ministries of Health, donors, public and private organizations/agencies acting as implementing partners and community based and civil society organizations with experience working on health, especially organizations familiar with similar testing campaigns for other disease programmes like HIV and malaria
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Policy Brief. 24 June 2022. This policy brief, one of two on the updated hepatitis C (HCV) guidelines, focuses on the new recommendations on simplified service delivery for a public health approach to HCV testing, care and treatment. These recommend
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ations include decentralization, integration and task-sharing, in addition to the use of point-of-care (POC) HCV viral load assays and reflex viral load testing.
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This joint ECDC-European Union Aviation Safety Agency (EASA) document aims to support Member States in determining a coordinated approach to reduce the risks related to the movement of people by air within and between the EU/EEA countries and the UK in the context of the COVID-19 pandemic, noting th
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at the impact of quarantine and testing is likely to vary according to levels of ongoing community transmission, and in the context of ECDC’s current advice that non-essential travel should be avoided during the end-of year festive period
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This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national mal
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aria control programmes, regulators, implementers and rapid diagnostic providers.
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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 tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference
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method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage.
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July 2021. This publication brings together important clinical and programmatic updates produced by WHO since 2016 and provides comprehensive, evidence-informed recommendations and good practice statements within a public health, rights-based and person-centred approach.
These guidelines bring in
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the most recent guidance on HIV testing strategies - the entry point for HIV prevention and treatment - and include comprehensive guidance on infant diagnosis. Key recommendations are presented on rapid antiretroviral therapy (ART) initiation and the use of dolutegravir. Updated recommendations are included on the timing of ART for people with TB, and the use of point-of-care technologies for treatment monitoring.
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This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
16 Dec. 2020
This document provides guidance to Ministries of Health (MOHs), laboratory personnel and implementing partners in African Union Member States on the application of rapid antigen tests to COVID-19
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testing. The guidance serves as reference for policymakers, laboratory leads, implementing partners, and experts on use case scenarios and associated testing algorithms for COVID-19 antigen tests. It recommends the use of antigen tests to increase access to testing and enable timely results for persons with or without symptoms in specific settings. The document will be reviewed and updated as more evidence becomes available regarding the use of rapid antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from global studies and evaluation efforts.
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Available in Arabic, Chinese, English, French, Portuguese and Spanish
https://apps.who.int/iris/handle/10665/334254
Tokar et al. Health Research Policy and Systems (2019) 17:23 https://doi.org/10.1186/s12961-019-0415-4
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 diagnostic tests available, on antigen test performance and accessibility. 1t focuses on
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key issues such as when to
Perform antigen tests′ how to use and interpret results. Capturing and reporting testing information is also covered.
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