Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha...rmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
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This manual is to assist health care providers and laboratory scientists to diagnose mycobacterium ulcerans disease (Buruli ulcer). The manual aims to achieve a better understanding of the clinical presentation and its diagnosis. The methods described are tailored to various levels of care and avail...able resources to improve the diagnosis and surveillance of the disease.
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Technical Report
AIDS Medicines and diagnostics service
September 2016
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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Aлгоритм лабораторной диагностики и мониторинга лечения туберкулеза легких и туберкулеза с лекарственной устойчивостью на основе применения современных быстрых... молекулярных методов.
Экспертное заключение членов основной группы Европейской лабораторной инициативы, подготовленное для Европейского региона ВОЗ.
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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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The WHO Cholera Rapid Diagnostic Test (RDT) Target Product Profile outlines the key requirements for developing improved cholera RDTs. It highlights the need for fast, accurate, and easy-to-use tests for early outbreak detection in resource-limited settings. The document sets desired and acceptable ...performance criteria, including high sensitivity and specificity, rapid results (under 15 minutes), and usability by non-laboratory personnel. The tests should be affordable, stable in extreme conditions, and require minimal training. The goal is to enhance cholera surveillance and outbreak response, ensuring quick containment and improved public health outcomes.
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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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PQDx 0197-045-00 WHO
PQDx PR
March /2016, version 2.0
PQDx 0033-013-00 WHO
PQ Public Report
July/2016, version 5.0
PQDx 0005-005-00
WHO PQDx PR
May/2016, version 3.0
The guidelines are primarily intended for health-care professionals working in first- or second-level health-care facilities, including emergency, inpatient and outpatient services. They are also directed at policy-makers, health-care planners and programme managers, academic institutions, non-gover...nmental and civil society organizations to inform capacity-building, teaching and research agendas.
Web annex A provides the quantitative evidence reports, Web annex B summarizes the qualitative and economic evidence and Web annex C presents the Evidence-to-Decision frameworks.
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