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.
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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
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9 March 2022, Timely and accurate diagnostic testing for SARS-CoV-2 is an essential part of a comprehensive COVID-19 response strategy. Ag-RDTs can be performed by individuals in which they collect their own specimen, perform a simple rapid test and interpret their test result themselves at a time a...nd place of their choosing, termed COVID-19 self-testing. This interim guidance provides a new recommendation that COVID-19 self-testing, using SARS-CoV-2 Ag-RDTs, should be offered as part of SARS-CoV-2 testing services. It also includes implementation considerations that can guide decisions on whether, and how, to adopt self-testing in different contexts, including the populations being prioritized; the disease prevalence in that population; and the impact on accessibility of testing, health care services and result reporting.
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Tuberculosis (TB) is the deadliest infectious disease in most low- and middle-income countries, claiming more than 4,000 lives each day. The unprecedented COVID-19 pandemic has seriously impacted people with pre-existing health conditions. People with TB are usually more vulnerable to other infectio...ns, including the novel coronavirus, due to pre-existing lung damage. They are also at higher risk of developing complications from COVID-19.
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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
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This document aims to provide interim guidance for microbiology and virology experts, other laboratory professionals, laboratory managers, infectious disease programme managers, public health professionals and other stakeholders that provide primary, confirmatory or advanced testing for SARS-CoV-2, ...including genomic sequencing, or are involved in making decisions on establishing or scaling up capability and capacity to detect and characterize circulating SARS-CoV-2 variants.
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Second edition. June 2022. This revised guidance recommends that access to COVID-19 testing is decentralized as far as possible and made available at health facilities, and through the use of self tests to enable access to care and the mitigation of transmission. Testing should be prioritized for hi...gh-risk and vulnerable individuals presenting with acute onset of respiratory illness so that those found to be infected can benefit from clinical care and access to COVID-19 therapeutics and vaccines
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he Framework sets the requirements for facilities handling High Consequence Agents and Toxins (HCATs) and guides the implementation of laboratory biosafety and biosecurity practices associated with the design, commissioning, routine operation safe and secure biocontainment laboratories.
The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u...se research.
The framework adopts the One health approach and focuses on the role that responsible life sciences research can play in preventing and mitigating risks caused by accidents, inadvertent or deliberate misuse with the intention to cause harm to humans, nonhuman animals, plants and agriculture, and the environment.
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The World Health Organization (WHO) recognizes the challenges countries face for maintaining their COVID-19 response while addressing competing public health challenges, conflicts, climate change and economic crises.
It remains critical for national programmes to continue to offer testing for COVI...D-19 in line with three main objectives: reduce morbidity and mortality through linkage to prompt care and treatment, reduce onward transmission and track the evolution of the epidemic and the virus
itself.
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To meet the need for laboratory diagnosis to be integrated in community care, the new 2022 Update describes point-of-care tests that can be performed both in district laboratories and peripheral healthcare facilities by non-specialist staff. Also included are recently developed self-tests.
Les notes d’orientation exposent les mesures essentielles que les décideurs peuvent mettre en œuvre aux niveaux national et infranational pour les éléments suivants : tests de diagnostic de la COVID-19, prise en charge clinique de la COVID-19, atteinte des cibles en matière de vaccination con...tre la COVID-19, maintien
des mesures de lutte anti-infectieuse contre la COVID-19 dans les établissements de santé, renforcement de la confiance grâce à la communication sur les risques et à la mobilisation communautaire et gestion de l’infodémie autour de la COVID-19.
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Los coronavirus son un grupo de virus ARN altamente diversos de la familia Coronaviridae que se dividen en
4 géneros: alfa, beta, gamma y delta, y que causan enfermedades de leves a graves en humanos y animales
(1-3). Existen coronavirus humanos endémicos como los alfacoronavirus 229E y NL63 y l...os betacoronavirus
OC43 y HKU1 que pueden causar enfermedades de tipo influenza o neumonía en humanos. Sin embargo,
tres betacoronavirus zoonóticos que pueden causar enfermedad severa en humanos han emergido: el
coronavirus del Síndrome respiratorio agudo grave (SARS-CoV), el coronavirus del Síndrome respiratorio de
Oriente Medio (MERS-CoV) y el virus de COVID-19 (SARS-CoV-2).
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Interium guidance, 25 June 2021Timely and accurate diagnostic testing is an essential tool in preventing and controlling the spread of COVID-19. This document describes recommendations for national testing strategies and the use of PCR and rapid antigen tests in different transmission scenarios of t...he COVID-19 outbreak, including how testing might be rationalized in low resource settings. All testing should be followed by a strong public health response including isolating those who test positive and providing them care, contact tracing and quarantine of contacts.
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The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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Probenmaterial für die PCR-Diagnostik zum direkten Erregernachweis
Verpackung und Versand
Empfehlungen zum Umgang mit Probenmaterial
Direkter Erregernachweis durch RT-PCR
Antikörpernachweise (indirekter Nachweis einer Infektion)
Antigennachweise
Bemerkungen zur Interp...retation von Laborergebnissen
Ansprechpartner zu Fragen der Labordiagnostik und Referenzuntersuchungen:
Konsiliarlabor für Coronaviren
Gesellschaft für Virologie
Ständig aktualisiert
Vorgehen bei Patienten mit bestätigter SARS-CoV-2-Infektion
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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 ...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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