This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distingu...ish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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July 2018
This fourth edition of the Unitaid/WHO market and technology landscape: HIV rapid diagnostic tests for self-testing report summarizes the current HIV testing gap; the challenges facing efforts to scale up; and the potential role HIV self-testing (HIVST) could play to achieve the United... Nation’s 90-90-90 targets. In particular, the report synthesises the existing and emerging market demand and supply of kits.
The information in this report is intended for manufacturers, donors, national programmes, researchers and other global health stakeholders who are exploring the potential role of HIVST.
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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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Guidelines
HIV testing services
July 2015
Supplement
HIV testing services
December 2016
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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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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Three classess of tests are now recommended in the latest consolidated guideles on tests for tuberculosis infection. It includes for the first-time a new class of Mycobacterium tuberculosis antigen-based skin tests (TBSTs), and the two existing classes of tests: the tuberculin skin test (TST) and t...he interferon-gamma release assays (IGRAs).
IGRAs and TBSTs use Mycobacterium tuberculosis complex specific antigens and represent a significant advancement to TST which has been used for over half a century.
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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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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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6 July 2021. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included.
The latest operational handbook includes the new classes recommended by WHO. It aims at facilitating the implementation of the WHO recommendations by the Member States, technical partners, and ot...hers involved in managing patients with TB and DR-TB. The operational handbook provides practical information on existing and new tests recommended by WHO, step-by-step advice on implementing and scale-up testing to achieve local and national impact and lastly, model diagnostic algorithms, which are updated to incorporate the latest recommendations. An overview of budgetary considerations and information sheets on each of the newly recommended tests is provided.
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These consolidated guidelines on HIV testing services (HTS) bring together existing and new guidance on HTS across different settings and populations.
The World Health Organization (WHO) first released consolidated guidelines on HTS in 2015, in response to requests from Member States, national pr...ogramme managers and health workers for support to achieve the United Nations (UN) 90–90–90 global HIV targets – and specifically the first target of diagnosing 90% of all people with HIV. In 2016, based on new evidence, WHO released a supplement to address important new HIV testing approaches – HIV self-testing (HIVST) and provider-assisted referral.
Since the release of 2015 and 2016 HTS guidelines, new issues and more evidence have emerged. To address this, WHO has updated guidance on HIV testing services. In this guideline, WHO updates recommendation on HIVST and provides new recommendations on social network-based HIV testing approaches and western blotting (see box, next page). This guideline seeks to provide support to Member States, programme managers, health workers and other stakeholders seeking to achieve national and international goals to end the HIV epidemic as a public health threat by 2030.
These guidelines also provide operational guidance on HTS demand creation and messaging; implementation considerations for priority populations; HIV testing strategies for diagnosis HIV; optimizing the use of dual HIV/syphilis rapid diagnostic tests; and considerations for strategic planning and rationalizing resources such as optimal time points for maternal retesting
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