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Diagnostic Target Product Profiles for Monitoring and Evaluation of Soil-Transmitted Helminth Control Programs.
ISBN: 9789240031227 Year: 2021 Publisher: Geneva : World Health Organization,

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This publication by the World Health Organization outlines the diagnostic target product profiles for monitoring and evaluation of helminth control programs. It addresses the public health response to parasitic worm infections, which affect millions globally, particularly in tropical regions with poor sanitation. The document discusses preventive measures, including the use of anthelminthic medications, and evaluates available diagnostic tools such as the Kato-Katz technique and newer methods like qPCR. The aim is to guide efforts in reducing the prevalence of helminth infections and to improve health outcomes in affected populations. Intended for public health professionals and policymakers, it provides a framework for effective control strategies.


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Surveillance Template Protocol for Pfhrp2/pfhrp3 Gene Deletions.
ISBN: 9789240002036 Year: 2020 Publisher: Geneva : World Health Organization,

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This publication by the World Health Organization outlines a surveillance protocol to monitor deletions in the pfhrp2 and pfhrp3 genes, which can cause false-negative results in rapid diagnostic tests (RDTs) for Plasmodium falciparum malaria. The protocol aims to assess the prevalence of these gene deletions, evaluate their impact on diagnostic accuracy, and inform potential changes in testing strategies at local and national levels. Targeting health facilities in malaria-endemic regions, the protocol involves cross-sectional surveys to collect data on suspected and confirmed cases of gene deletions. It provides guidelines for the selection of sites, sample sizes, and data collection methods, emphasizing the importance of accurate diagnosis in malaria management. This work is intended for researchers, healthcare professionals, and policy-makers involved in malaria control and prevention.


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WHO Standard : Universal Access to Rapid Tuberculosis Diagnostics.
ISBN: 9789240071315 Year: 2023 Publisher: Geneva : World Health Organization,

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This publication by the World Health Organization (WHO) outlines the standards for universal access to rapid tuberculosis diagnostics. Aimed at healthcare professionals and policymakers, it provides a comprehensive framework to improve TB diagnostic processes globally. The book details steps for identifying TB symptoms, accessing testing, and receiving diagnoses, emphasizing the need for widespread availability and use of rapid diagnostic tests. It also discusses barriers and enablers in implementing these standards and presents strategies for scaling up diagnostic access through case studies. The document highlights WHO's coordinated efforts and collaboration with global experts to enhance TB diagnostics, thereby aiming to control and eventually eradicate tuberculosis worldwide.


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Diagnostic Test for Lymphatic Filariasis to Support Decisions for Stopping Triple-Therapy Mass Drug Administration : Target Product Profile.
ISBN: 9789240018624 Year: 2021 Publisher: Geneva : World Health Organization,

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This publication by the World Health Organization focuses on the development of a diagnostic test for lymphatic filariasis to support decisions for stopping mass drug administration (MDA) programs. The text outlines the need for a reliable diagnostic tool to evaluate the effectiveness of triple-therapy mass drug administration in reducing transmission of this mosquito-borne parasitic disease, which affects millions globally. The book highlights the disease's impact, current diagnostic methods, and the WHO's strategic approach to elimination through the Global Programme to Eliminate Lymphatic Filariasis (GPELF). Intended for health professionals and policy makers, the text provides guidance on product design, performance, and implementation considerations.


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Protocol for the Performance Evaluation of Rapid Diagnostic Tests for the Detection of Vibrio Cholerae O1 or O1/O139 for WHO Prequalification Assessment, PQDx_305 Version 2.
ISBN: 9240075046 9789240075047 Year: 2024 Publisher: Geneva : World Health Organization,

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This protocol, published by the World Health Organization in 2023, provides a comprehensive guide for the performance evaluation of rapid diagnostic tests for detecting Vibrio cholerae O1 or O19. Aimed at Performance Evaluation Laboratories and manufacturers of in vitro diagnostics, the document outlines procedures for assessing the accuracy, sensitivity, specificity, and operational ease of use of these tests in laboratory settings. It emphasizes compliance with WHO requirements and is designed to ensure suitability for use in resource-limited environments. The protocol includes detailed instructions on specimen collection, data analysis, quality control measures, and ethical considerations, making it an essential resource for those involved in the evaluation of diagnostic tools for cholera detection.

FDA regulation of laboratory-developed tests (LDTs)
Authors: ---
Year: 2020 Publisher: [Washington, D.C.] : Congressional Research Service,

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Report of the Third Meeting of the WHO Onchocerciasis Technical Advisory Subgroup, Geneva, Switzerland, 26-28 February 2019.
ISBN: 9789240006638 Year: 2020 Publisher: Geneva : World Health Organization,

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This report details the proceedings of the third meeting of the WHO Technical Advisory Subgroup on Onchocerciasis, held in Geneva from February 26 to 28, 2019. The meeting focused on evaluating diagnostic tools for onchocerciasis, including comparisons of various ELISA platforms and rapid diagnostic tests (RDTs). Discussions included elimination mapping strategies and milestones for achieving the 2030 Sustainable Development Goals related to onchocerciasis. The report serves as a resource for health professionals and policymakers engaged in the control and elimination of neglected tropical diseases, providing insights into diagnostic advancements and strategic planning for disease elimination.


Book
Profils de Produit Cible Pour les Tests de Diagnostic de l'orthopoxvirose Simienne (variole Simienne).
ISBN: 9240079513 9789240079519 Year: 2024 Publisher: Geneva : World Health Organization,

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This publication by the World Health Organization (WHO) provides target product profiles for diagnostic tests used in the detection of mpox (monkeypox). It aims to guide the development and evaluation of effective diagnostic tools, particularly in response to the global spread of the monkeypox virus (MPXV) since May 2022. The document outlines the minimum and desired targets for diagnostic tests, emphasizing the need for accurate, rapid, and widely accessible testing methods to manage and control outbreaks. Targeted at healthcare professionals, researchers, and policymakers, this guide also highlights the collaborative effort among international experts to standardize testing procedures and improve public health responses.


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Perfiles de Producto para Las Pruebas de Diagnóstico de la Viruela Símica.
ISBN: 9240079491 9789240079496 Year: 2024 Publisher: Geneva : World Health Organization,

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This publication by the World Health Organization (WHO) provides detailed profiles for diagnostic tests used in the diagnosis of mpox (monkeypox). It outlines target product profiles for these tests, aiming to guide the development and implementation of diagnostic tools in response to the mpox outbreak. The document emphasizes the need for accurate laboratory confirmation through nucleic acid amplification tests, such as PCR, to identify suspected cases efficiently. It also addresses the global health implications due to the widespread cases reported since May 2022, highlighting the urgency of effective diagnostic measures. The intended audience includes healthcare professionals, laboratory technicians, and public health officials involved in disease surveillance and outbreak management.


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用于猴痘诊断检测的目标产品概况.
ISBN: 9789240079571 Year: 2024 Publisher: Geneva : World Health Organization,

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This publication by the World Health Organization outlines the target product profiles (TPPs) for diagnostic tests used in the detection of mpox (monkeypox). It provides detailed descriptions of both minimal and preferred targets for these diagnostic tests, aiming to guide developers and policymakers in the creation and implementation of effective testing strategies. The document is intended for use by healthcare professionals, researchers, and public health officials involved in infectious disease management and policy formulation. The text is structured to offer comprehensive insights into the required standards and expectations for diagnostic products, promoting improved public health responses to mpox outbreaks.

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