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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-...ing. The Africa CDC recommends the use of rapid antigen self-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
Limited coverage of laboratory services and long turnaround times from real-time reverse transcription-polymerase chain reaction (rRT-PCR) for the detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been insufficient to meet the demands in many African countries in response...
Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19
recommended
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 ... Testing for Diagnosis of COVID-19. This framework aims to provide 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.
SARS-COV-2 antigen rapid diagnostic tests are an alternative option for diagnosing active SARS-CoV-2 infection through detection of viral proteins....
All personnel performing SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDT) need to understand how to safely perform ...ing, 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 modules, which include recorded presentations and videos.
Availble in different languages
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 ...s 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.
This guide provides an overview of the major elements that must be considered before, during and after the implementation of antigen-detecting rapid diagnostic ...s (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
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 ... test and interpret their test result themselves at a time and 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.
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 te...s, 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.
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 ad...
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 test...
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 ... Testing for Diagnosis of COVID-19. This framework aims to provide 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.
Juni 2021. Flyer zu Antigentests
In zahlreichen Sprachen herunterzuladen
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 durc...
Laboratory biosafety guidance related to coronavirus disease (COVID-19): Interim guidance, 28 January 2021
recommended
The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic ...;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protective 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.
The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic ...;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protective 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.
The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic ...;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protective 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.
