18 Janaury 2021
EU/EEA Member States and the UK have increased their laboratory capacity tremendously over the past 11 months as the majority of the Member States reported sufficient testing capacity until March 2021.
Many countries are adding rapid antigen detection tests (RADT) to their ...testing strategies in order to reduce pressure on RT-PCR testing.
Some Member States have already included RADT in their case definition.
The main bottlenecks, such as shortages of laboratory consumables and human resources, as well as sample storing facilities, continue to exist and may affect the overall laboratory response to COVID-19.
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04.März 2021
MEDBOX Issue Brief no. 10
Dieser Issue Brief gibt einen kurzen Überblick über Teststrategie, Testverfahren, Videos zur Handhabung und weiterführende Literatur.
Two test methods on dexamethasone tablets and injections
The growing understanding of how sequence information can contribute to improved public health is driving global investments in sequencing facilities and programmes. The falling cost and complexity of generating GSD provides opportunities for expanding sequencing capacity; however, challenges to wid...espread implementation remain. This document provides policy-makers and stakeholders with guidance on how to maximize the public health benefit of SARS-CoV-2 genomic sequencing activities in the short and long term as the pandemic continues to unfold. Practical considerations for the implementation of a virus genomic sequencing programme and an overview of the public health objectives of genomic sequencing are covered. This guidance focuses on SARS-CoV-2 but is applicable to other pathogens of public health concern.
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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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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.
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Dexametasona en comprimimidos
Dexametasona inyectable
orientations provisoires, 25 juin 2021. Des tests de diagnostic rapides et précis sont un outil essentiel pour prévenir et contrôler la propagation du COVID-19. Ce document décrit les recommandations relatives aux stratégies nationales de dépistage et à l'utilisation de la PCR et des tests an...tigéniques rapides dans différents scénarios de transmission de l'épidémie de COVID-19, y compris la manière dont les tests pourraient être rationalisés dans les milieux à faibles ressources. Tous les tests doivent être suivis d'une réponse de santé publique forte, comprenant l'isolement des personnes dont le test est positif et la fourniture de soins, la recherche des contacts et la mise en quarantaine des 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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8 January 2021
Sequencing enabled the world to rapidly identify SARS-CoV-2 and develop diagnostic tests and other tools for outbreak management. Continued genome sequencing supports the monitoring of the disease’s spread and evolution of the virus. Accelerated integration of genome sequencing int...o the practices of the global health community is required if we want to be better prepared for the future threats. This document provides guidance for laboratories on maximizing the impact of SARS-CoV-2 sequencing now and other emerging pathogens in the future.
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28 Jan. 2021. L’objet de ce document est de fournir des orientations provisoires sur la sécurité biologique en laboratoire applicable à l’analyse d’échantillons cliniques issus de patients.
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
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Обновленная версия. В этой версии приведены обновленные рекомендации относительно стратегии диагностического тестирования в контексте обновлённой классификаци...и способов передачи, мер общественного здравоохранения и социальных мер, эпиднадзора за общественным здравоохранением и установленных ВОЗ определений случая COVID-19. В данном руководстве учтено использование новых инструментов, таких, как диагностические экспресс-тесты для выявления антигенов (ДЭТ-АГ) и аспекты тестирования привитых лиц, а также тестирования на генетические мутации, связанные с вариантами. Кроме того, для этой версии разработаны приложения, включая подборку полезных ресурсов и десять компонентов расширения тестирования на субнациональном уровне.
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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.
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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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Orientations provisoires, 28 janvier 2021
Dans cette version mise à jour des orientations sur la sécurité biologique en laboratoire en rapport avec le SARS-CoV-2, le virus responsable de la maladie à coronavirus 2019 (COVID-19), les points suivants ont été ajoutés : aspects de... sécurité biologique relatifs à la réalisation des tests diagnostiques rapides antigéniques, manipulation des nouveaux variants du SARS-CoV-2 au laboratoire, mise à jour de la décontamination des tests avant leur élimination, équipement de protection individuelle (EPI) pour le prélèvement d’échantillons et, même s’ils ne concernent pas directement la sécurité biologique, dangers chimiques et leur élimination en toute sécurité.
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deux méthodes d'essai sur les comprimés et les injections de dexaméthasone