This document updates recommendations for HIV testing by laboratories in the United States and offers approaches for reporting test results to persons ordering HIV tests and to public health authorities. The recommended algorithm is a sequence of tests used in combination to improve the accuracy of ...the laboratory diagnosis of HIV based on testing of serum or plasma specimens. The updated recommendations also include tests for HIV antigens and HIV nucleic acid because studies from populations at high risk for HIV demonstrate that antibody testing alone might miss a considerable percentage of HIV infections detectable by virologic tests
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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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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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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.
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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
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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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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.
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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.
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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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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... to the COVID-19 pandemic. Rapid antigen diagnostic tests (AgRDTs) are potentially useful as they can inform healthcare workers and individuals of their infection status at point-of-care testing
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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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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
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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
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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
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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.
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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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