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Options for the use of rapid antigen tests for COVID-19 JD
clinical validations of rapid antigen tests. Summary ... Timely and accurate COVID-19 testing is an essential part of surveillance, contact tracing, infection prevention and ... The EU regulatory framework for diagnostic tests Reagents, control materials, testing kits, and instruments intended for medical use are referred to as in vitro ...
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COVID-19 and schools transmission
www.ecdc.europa.euAvailable evidence to date indicates that children most probably contract COVID-19 in their ... These decisions were based on what is known of the ... [13]. Children with disabilities may be particularly affected as they can feel more isolated when schools and special services are closed . children . 6 (%) children
SURVEILLANCE REPORT: Antimicrobial resistance …
www.ecdc.europa.euv SURVEILLANCE REPORT Antimicrobial resistance surveillance in Europe 2014 3.29. Streptococcus pneumoniae. Total number of tested isolates (N) and percentages non-susceptible to macrolides (%IR), including 95 % confidence intervals (95 % …
TECHNICAL DOCUMENT - European Centre for Disease ...
www.ecdc.europa.euTECHNICAL DOCUMENT Social marketing guide for public health managers and practitioners 1 Summary The ECDC Social Marketing guide provides public health programme managers and practitioners with a summary of social marketing concepts and approaches.
Suspected adverse reactions to COVID-19 vaccination and ...
www.ecdc.europa.euDuring the same period, 354 177 (0.2%) cases of suspected adverse reactions after vaccination were reported to EudraVigilance [15] (Table 1). The vast majority of suspected adverse reaction reports so far relate to general reactions and the administration site (e.g. ‘flu-like’ illness, headache, pain at the application site, chills, fatigue,
Interim public Health considerations for COVID-19 ...
www.ecdc.europa.euvaccinating at least 80% of people over the age of 80 years and 80% of health and social care professionals in every Member State by March. In addition, a minimum of 70% of the adult (18 years and older) population were to be vaccinated by the summer [5]. EU/EEA countries initially prioritised vaccination of older adults, residents
Heating, ventilation and air-conditioning systems in the ...
www.ecdc.europa.eurequired air exchanges during customary use are proposed by the American Society of Heating Refrigerating and Air-Conditioning Engineers (ASHRAE) as 7-10 L/s per person [33] . The Federation of European H eating, Ventilation and Air Conditioning Associations (REHVA) recommends ensuring the minimum number of air
Implications of the emergence and spread of the SARS-CoV …
www.ecdc.europa.euTHREAT ASSESSMENT BRIEF Implications for the EU/EEA on the emergence and spread of the SARS-CoV-2 B.1.1.529 variant 3 Omicron properties The variant B.1.1.529 (Omicron) belongs to Pango lineage B.1.1.529, Nextstrain clade 21K [11], and is characterised by 30 amino acid changes, three small deletions and one small insertion in the spike protein
Threat assessment brief - Emergence of SARS-CoV-2 variant ...
www.ecdc.europa.euTHREAT ASSESSMENT BRIEF Implications for the EU/EEA on the spread of the SARS-CoV-2 B.1.1.529 variant – first update 3 across the region, but these are under investigation. The majority of confirmed cases have a history of travel to southern African countries, with some having taken connecting flights at other destinations between Africa and
Surveillance of antimicrobial resistance in Europe, 2020 data
www.ecdc.europa.euSince the adoption of the European Strategic Action Plan on Antibiotic Resistance in 2011 and the publication (1) of the Global Action Plan on Antimicrobial Resistance (GAP-AMR) in 2015 , most Member States of the WHO (2) European Region have enhanced efforts to tackle AMR. Only 25 (50%) of the 50 countries reported having devel-
CDTR Week 49, 5-11 December 2021
www.ecdc.europa.euEU Threats On 31 December 2019, the Wuhan Municipal Health and Health Commission reported a cluster of pneumonia cases of unknown aetiology with a common source of exposure at Wuhan's South China Seafood City market. Further investigations identified a novel coronavirus as the causative agent of respiratory symptoms for these cases.
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QAPI TOOLKIT - Medline Industries
www.medline.comregulatory compliance. Barbara has served on various committees and subcommittees, and has presented at numerous workshops and conventions. As a member of the Centers for Medicare and Medicaid Services (CMS) Technical Expert Panel (TEP), she was part of the QAPI demonstration project. Barbara served as
EudraVigilance - EVWEB User Manual
www.ema.europa.eupresentation during all phases of the drug regulatory process (i.e. the pre- and post-authorisation phase). These processes include clinical studies, reports of spontaneous adverse reactions, events, regulatory submissions and regulated product …
Center for Clinical Standards and Quality/Survey ...
www.cms.govAug 26, 2020 · Certificate of Compliance (CoC) and Certificate of Registration (CoR) CoC and CoR laboratories will be assessed for compliance with the reporting requirement at 493.1100(a) at the time of an initial, recertification, or complaint survey. Review of a laboratory’s reporting documentation should be incorporated into the routine survey process.
COVID-19 rapid antigen self-tests
www.tga.gov.auCOVID-19 rapid antigen self-tests. This guidance refe rs to COVID -19 (caused by SARS-CoV-2) only and does not include self-tests to detect other types of coronavirus , or COVID_19 rapid antibody tests . COVID-19 rapid antigen self-tests are tests that allow individuals to collect a specimen, conduct a test and interpret the results by themselves.
The GSPRs (General Safety and Performance Requirements ...
d2evkimvhatqav.cloudfront.netManufacturers must now demonstrate compliance with the general safety and performance requirements, the GSPRs, that provide broad, high-level criteria for safety and performance applicable to design, production, and post-production aspects, throughout the lifecycle of all IVDs. Manufacturers that have demonstrated compliance under