SOP- Quality Assurance of Malaria Diagnostic Tests
Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on medi
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cal device donation in 2011, which has been now reviewed, with new evidence, new references on considerations for medical device solicitation and provision, risks associated with inappropriate donations, the responsibilities of donors and recipient, and the steps they should follow before, during and after a donation. It includes three sections: description of major problems that may be faced during the donation process, listing of best practices for donors and recipients and addressing situations requiring special attention. It also has three annexes for further reading: the criteria for the acceptability of a donation, literature review on donations of medical devices between 2010 and 2023 and a flyer. This document is intended to improve the quality of medical devices donations, including medical equipment, single-use medical devices and in-vitro diagnostics, to provide maximum benefit to all stakeholders. The considerations can be used to develop institutional or national policies and regulations for medical devices donations. This document is intended for use by any organization, expert or practitioner involved in the donation, procurement, management of medical devices, including health workers, biomedical engineers, health managers, policymakers, donors, nongovernmental organizations and academic institutions.
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Copenhagen, Denmark, 24–25 August 2017
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 recommendatio
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ns by the Member States, technical partners, and others 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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Hepatitis B (HBV) infection is a major public health problem and cause of chronic liver disease.
The 2024 HBV guidelines provide updated evidence-informed recommendations on key priority topics. These include expanded
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and simplified treatment criteria for adults but now also for adolescents; expanded eligibility for antiviral prophylaxis for pregnant women to prevent mother-to-child transmission of HBV; improving HBV diagnostics through use of point-of-care HBV DNA viral load and reflex approaches to HBV DNA testing; who to test and how to test for HDV infection; and approaches to promote delivery of high-quality HBV services, including strategies to promote adherence to long-term antiviral therapy and retention in care.
The 2024 guidelines include 11 updated chapters with new recommendations and also update existing chapters without new recommendations, such as those on treatment monitoring and surveillance for liver cancer.
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The intent of these guidelines is to develop a holistic, coordinated, proactive and technology driven strategy for management of biological disasters through a culture of prevention, mitigation
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and preparedness to generate a prompt and effective response in the event of an emergency. The document contains comprehensive guidelines for preparedness activities, biosafety and biosecurity measures, capacity development, specialised health care and laboratory facilities, strengthening of the existing legislative/
regulatory framework, mental health support, response, rehabilitation and recovery, etc. It specifically lays down the approach for implementation of the guidelines by the central ministries/departments, states, districts and other stakeholders, in a time bound manner.
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Polymerase Chain Reaction (PCR) has significantly helped in early diagnosis and commencement of specific interventions for diseases control. It also plays a critical role in understanding the disease epidemiology
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and unraveling the transmission dynamics of the disease. This manual intends to provide primary guidelines to assist health lab personnel in developing countries to establish a PCR diagnostic facility for efficient support to patient care as well as public health actions.
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The overall goal of the programme, to reduce the malaria morbidity and mortality by 75% (using 2012 as baseline) by the year 2020, continued to be pursued in 2014. The following areas were identified as some of the priorities for the year: Malaria C
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ase Management under which we have Malaria in Pregnancy (MIP), Home Based Care and Diagnostics.
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The Strategy provides a high-level unifying framework to leverage existing capacities, address barriers and strengthen the use of genomic surveillance in the detection, monitoring and response to pu
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blic health threats. Genomic surveillance is part of the broader surveillance and laboratory system, and its implementation should reinforce end-to-end capacities including sample collection, diagnostics, data sharing and analysis. The strategy aims to facilitate the connectivity between different disease control programs and surveillance networks. This interoperability will strengthen the cross-cutting essential public health laboratory functions underpinning genomics holistically. The strategy articulates the overarching goal, objectives and strategic actions needed. These are dependent on commitments from countries, partners and WHO for their implementation.
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Second Edition
AIDS Medicines and diagnostics services
July 2015
Due to the anticipated significant rise in VL testing occasioned by Ghana’s adaptation of 2016 ART guidelines, it has become necessary to develop this VL scale-up and operational plan to assure complete client access to
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laboratory monitoring towards the achievement of the third 90 of the HIV care cascade. The plan will enhance VL testing, monitoring whilst improving the clinical and laboratory interface for improved client care.
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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
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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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Technical and operational ‘how-to’: practical considerations
Lancet Oncol 2022; 23: e251–312Published OnlineMay 9, 2022 https://doi.org/10.1016/S1470-2045(21)00720-8
In sub-Saharan Africa (SSA), urgent action is needed to curb a growing crisis in cancer incidence and mortality.
Without rapid interventions
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, data estimates show a major increase in cancer mortality from 520 348 in 2020 to about
1 million deaths per year by 2030. Here, we detail the state of cancer in SSA, recommend key actions on the basis of
analysis, and highlight case studies and successful models that can be emulated, adapted, or improved across the
region to reduce the growing cancer crises. Recommended actions begin with the need to develop or update national
cancer control plans in each country. Plans must include childhood cancer plans, managing comorbidities such as
HIV and malnutrition, a reliable and predictable supply of medication, and the provision of psychosocial, supportive,
and palliative care. Plans should also engage traditional, complementary, and alternative medical practices employed
by more than 80% of SSA populations and pathways to reduce missed diagnoses and late referrals. More substantial
investment is needed in developing cancer registries and cancer diagnostics for core cancer tests.
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6 July 2021. The “WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection 2021 update” is the latest document replacing the one issued in 2020. Three new nucleic acid amplification test (NA
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AT) classes are endorsed by WHO and included in the latest consolidated guideline
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Policy Brief. 24 June 2022. This policy brief, one of two on the updated hepatitis C (HCV) guidelines, focuses on the new recommendations on simplified service delivery for a public health approach to HCV testing, care and treatment. These recommend
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ations include decentralization, integration and task-sharing, in addition to the use of point-of-care (POC) HCV viral load assays and reflex viral load testing.
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