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 ...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.
more
Frequenz, Adhärenz und Testqualität sind entscheidende Faktoren für den Erfolg
Epidemiologisches Bulletin17 |29. April 2021 . Im vorliegenden Artikel wird erläutert, wie Antigen-Schnelltests zur Pandemiekontrolle beitragen können. Außerdem werden die Chancen und Herausforderungen einer wiede...rholten Testung zur Reduktion des allgemeinen Transmissionsgeschehens und der zu erwartende Einfluss eines freiwilligen Testangebots auf das allgemeine Infektionsgeschehen diskutiert
more
Die Liste wird kontinuierlich aktualisiert und beinhaltet die entsprechenden Tests zur professionellen Anwendung, die sich nach aktueller Kenntnis des BfArM in Deutschland in Verkehr befinden und laut den Herstellerangaben die jeweils aktuellen durch das Paul-Ehrlich-Institut (PEI) in Abstimmung mit... der Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen.
more
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 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.
more
This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data management considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen sel...f-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
more
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 Antigen-Tests zum dir...ekten 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.
more
Journal of Tropical Pediatrics, 2020, 00, 1–5
doi: 10.1093/tropej/fmaa072
Brief Repor
Juni 2021. Flyer zu Antigentests
In zahlreichen Sprachen herunterzuladen
Весь персонал, проводящий экспресс-диагностику антигена SARS-CoV-2 (Ag-RDT), должен понимать, как безопасно проводить тестирование, обеспечивать качество тестирования и и...нтерпретировать результаты. Этот курс был разработан ВОЗ и FIND, Глобальным альянсом по диагностике, для предоставления теоретических знаний по тестированию SARS-CoV-2 Ag-RDT. Учебный пакет состоит из 10 модулей, включающих видео и презентации
more
La détection directe des protéines virales du SRAS-CoV-2 (antigènes) dans les écouvillons nasaux et autres sécrétions respiratoires à l'aide de tests immunologiques à flux latéral (également appelés tests de diagnostic rapide, TDR) offre une méthode plus rapide et moins coûteuse pour te...ster le SRAS-CoV-2 que la méthode de référence, les tests d'amplification des acides nucléiques (TAAN). Ces lignes directrices provisoires offrent des recommandations sur les utilisations prioritaires des tests de diagnostic rapide à détection d'antigène (TDR-Ag) dans des populations et des contextes spécifiques, notamment (i) pour la détection primaire des cas chez les personnes symptomatiques suspectées d'être infectées et les personnes asymptomatiques à haut risque de COVID-19, (ii) pour la recherche des contacts, (iii) pendant les enquêtes sur les épidémies et (iv) pour surveiller les tendances de l'incidence de la maladie dans les communautés. Les TDR-AG répondant aux exigences minimales de performance peuvent être utilisés en dehors des milieux cliniques et des laboratoires, y compris dans les communautés, par des opérateurs formés conformément aux instructions. Le guide fournit en outre des recommandations sur la mise en œuvre, la sélection des produits et le stockage
more
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...les, which include recorded presentations and videos.
Availble in different languages
more
22. Februar 2021
Das Epidemiologische Bulletin 8/2021 beschreibt die Chancen, aber auch Risiken und Limitationen bei der Eigenanwendung von Antigen-Selbsttests zum Nachweis einer akuten Infektion mit SARS-CoV-2.
Pflegeheime und Krankenhäuser können Antigen-Schnelltests nutzen, um Personal, Besucher sowie Patienten und Bewohner regelmäßig auf das Corona-Virus zu testen. Außerdem können die Schnelltests nun auch in Schulen eingesetzt werden. Eine entsprechende Änderung der Medizinprodukte-Abgabeverordn...ung ist am 4. Dezember in Kraft getreten. Warum Antigentests eingesetzt werden sollen und weitere Fragen und Antworten, finden Sie hier
more
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 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
more
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...ovide general technical guidance to African Union Members States on the rollout, establishment, implementation, monitoring, and evaluation of SARS-CoV-2 Ag RDT interventions so as to effectively and efficiently detect, control and minimise errors in the performance of COVID-19 laboratory testing processes. It describes the core components for quality assurance, resources mobilisation and advocacy for scale up, monitoring, evaluation, learning and accountability for SARS-CoV-2 implementation.
more
SARS-COV-2 antigen rapid diagnostic tests are an alternative option for diagnosing active SARS-CoV-2 infection through detection of viral proteins. Rapid antigen tests revolutionize the response to COVID-19 by providing accurate test results in 10 to 20 minutes instead of days, allowing tests to be ...done at point of care, and dramatically lowering the price of the tests.
Proper training on the safe use and implementation of antigen tests is vital to ensuring quality testing. A comprehensive training package around safety, sample collection, testing, reporting and management of antigen tests can be found below.
The training package includes facilitators’ guides for master trainers and trainers, training presentations, and supplementary materials to aid in the delivery of this training.
more
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 key issues such as when to
Perform antigen tests... how to use and interpret results. Capturing and reporting testing information is also covered.
more