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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Policy Brief.
WHO recommends that pregnant women receive testing for HIV, syphilis and hepatitis B (HBSAg) at least once during pregnancy, preferably in the first trimester.
Dual HIV/syphilis rapid diagnostic tests (RDTs) can be used as the first test for pregnant women as part of antenatal care (...ANC).
These simple tests can be used at the point-of-care and are cost-saving compared to standard testing in ANC. They enable more women to be diagnosed with HIV and syphilis so that they can access treatment and prevent transmission to their children.
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L’OMS recommande aux femmes enceintes de faire un test de dépistage du VIH, de la syphilis et de l’hépatite B (HBsAg) au moins une fois pendant la grossesse, de préférence au cours du premier trimestre. Le double test de diagnostic rapide (TDR) VIH/syphilis peut être utilisé comme premier ...test pour les femmes enceintes dans le cadre des soins prénataux. Ces tests simples peuvent être utilisés sur le lieu de soins et sont économiques par rapport aux tests standards de soins prénataux.
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L’expansion de la mise en œuvre des approches de suivi du traitement par la réalisation de tests de mesure de la charge virale et de tests de diagnostic chez le nourrisson sera indispensable pour garantir la qualité des soins et des traitements ainsi que le succès des programmes. Le fait de ch...oisir le réseau de diagnostic, les types d’échantillons ainsi que les interventions et les stratégies les plus appropriés dans chaque pays et pour chaque partenaire au niveau national et régional permettra de soutenir cet effort, de renforcer la collaboration et d’optimiser les investissements réalisés dans la mise en œuvre des tests en vue d’obtenir des effets manifestes.
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Available in Arabic, Chinese, English, French, Portuguese and Spanish
https://apps.who.int/iris/handle/10665/334254
Available in English, French, Spanish, Chinese, Russian and Arabic
https://apps.who.int/iris/handle/10665/337832
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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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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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 purpose of this TPP is to communicate the minimum and ideal characteristics desired to meet the need for discriminating low levels of risk for transmission, i.e. targeted prevalence thresholds in the surveyed areas. An in vitro diagnostic test is needed for the detection of analyte(s) specific t...o Wuchereria bancrofti, Brugia malayi, and Brugia timori to aid in the surveillance of defined geographic areas as to whether infection and/or transmission potential has increased (recrudescence) or decreased (elimination of transmission).
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Tuberculosis (TB) is the deadliest infectious disease in most low- and middle-income countries, claiming more than 4,000 lives each day. The unprecedented COVID-19 pandemic has seriously impacted people with pre-existing health conditions. People with TB are usually more vulnerable to other infectio...ns, including the novel coronavirus, due to pre-existing lung damage. They are also at higher risk of developing complications from COVID-19.
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FIND and Standard Diagnostics (SD) have developed a lateral flow rapid diagnostic test (RDT) to screen for
T.b. gambiense HAT that is cheap and easy to use. The tests are packed individually and are stable at 40°C for
up to 25 months; they are performed on fresh blood obtained from a finger prick..., and no instrument or electricity is required. The RDT detects host antibodies to infection in populations that are at risk, or in suspect individuals. Positive cases are subjected to further confirmatory methods to identify HAT patients.
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Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including malaria, HIV and COVID-19. Visually interpreted RDTs, more than any other class of diagnostics, fulfil WHO’s ASSURED criteria,1 enabling their... use at the lowest levels of health care and in self-testing.2 Their utility is, however, compromised every time a test is incorrectly performed or interpreted or its result is not available in a timely manner for clinical decisionmaking and surveillance.
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