The overall objective of this implementation plan is to define the strategy for implementation of the Xpert MTB/RIF test for rapid detection of TB and rifampicin (RIF) resistance in Tanzania, within the context of the National Tuberculosis and Leprosy Programme (NTLP) strategic plan and other nation...al health guidelines. It is intended to serve as the main guiding document for national, regional and local programme managers, clinicians, coordinators, laboratory staff and other health workers; national and regional reference laboratories; local and international implementing partners; and donors involved in TB control.
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Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
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Zika and dengue viruses remain significant public health threats. These viruses share the same Aedes (Stegomyia) mosquito vectors and geographic distributions but infections cannot be readily distinguished clinically and need to be differentiated from each other, and from other circulating arboviral... and non-arboviral pathogens, using laboratory tests. This document provides guidance on current testing strategies for Zika and dengue virus infections with updates to the previous interim guidance for laboratory testing for ZIKV, addressing pregnant and non-pregnant patients respectively, and incorporates current guidance for dengue virus diagnostic testing. The choice of laboratory assays and interpretation of test results require careful consideration of epidemiology, patient history, and limitations of existing diagnostic tests.
This interim guidance is for use by staff of laboratories testing for Zika and dengue virus infections and for clinical practitioners and public health professionals providing clinical management or surveillance.
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Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory... tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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This Rapid Advice Guideline updates the Interim Guidance on the “Assessment of infants with microcephaly in the context of Zika virus” published in February 2016 (WHO/ZIKV/MOC/16.3). The recommendations provides guidance on the screening, clinical assessment, neuroimaging, laboratory investigati...on and follow-up of children born to women living in areas of Zika virus transmission. The Guideline summarises the evidence base and rationale in support of the recommendations and expands the scope to address complications beyond microcephaly and what is now referred to as the congenital Zika virus syndrome
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Technical Report
AIDS Medicines and diagnostics service
July 2015
Policy brief. HIV testing services (HTS) and anti-retroviral therapy (ART) have been scaled up substantially. It is estimated that, globally, nearly 80% of people with HIV now know their status. With the offer of immediate ART initiation and improved treatment options, access to and uptake of treatm...ent have increased, too. Now, most people with HIV who know their status are obtaining treatment and care.
In response to these changes in the global HIV epidemic, WHO is encouraging countries to use three consecutive reactive tests for an HIV-positive diagnosis as their treatment-adjusted prevalence and national HTS positivity fall below 5% .
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This document is an evidence-based policy for the implementation of sound tuberculosis (TB) infection control by all stake- holders. It recommends a combination of measures aimed at reducing the risk of TB transmission within populations. The emphasis is on early and rapid diagnosis, and proper mana...gement of TB patients.
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Whole-genome sequencing (WGS) provides a vast amount of information and the highest possible resolution for pathogen subtyping. The application of WGS for global surveillance can provide information on the early emergence and spread of AMR and further inform timely policy development on AMR control.... Sequencing data emanating from AMR surveillance may provide key information to guide the development of rapid diagnostic tools for better and more rapid characterization of AMR, and thus complement phenotypic methods. This document addresses the applications of WGS for AMR surveillance, including the benefits and limitations of current WGS technologies
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Available in Arabic, Chinese, English, French, Portuguese and Spanish
https://apps.who.int/iris/handle/10665/334254
Available in Arabic, Chinese, English, French, Portuguese, Russian and Spanish
https://apps.who.int/iris/handle/10665/334254
July 2021. This publication brings together important clinical and programmatic updates produced by WHO since 2016 and provides comprehensive, evidence-informed recommendations and good practice statements within a public health, rights-based and person-centred approach.
These guidelines bring in... the most recent guidance on HIV testing strategies - the entry point for HIV prevention and treatment - and include comprehensive guidance on infant diagnosis. Key recommendations are presented on rapid antiretroviral therapy (ART) initiation and the use of dolutegravir. Updated recommendations are included on the timing of ART for people with TB, and the use of point-of-care technologies for treatment monitoring.
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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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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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Les notes d’orientation décrivent les mesures essentielles que les décideurs nationaux et infranationaux peuvent mettre en place concernant les aspects suivants de la lutte contre la COVID-19 : les tests de diagnostic, la prise en charge clinique, la réalisation des cibles en matière de vaccin...ation, le maintien des mesures de lutte anti-infectieuse liées à la maladie dans les établissements de soins de santé, les efforts
visant à instaurer la confiance par la communication sur les risques et la participation communautaire ainsi que la gestion de l’infodémie liée à la COVID-19.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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Cholera is a transmissible diarrhoeal infection caused by Vibrio cholerae. Endemic and/or epidemic in over 40 countries (mainly in Africa and Asia), cholera continues to be a major global public health issue.
The World Health Organization (WHO) estimates that the number of cases reported worldwid...e represents in reality only 5 to 10% of actual cases.
This guide is intended for medical and non-medical staff responding to a cholera outbreak. It attempts to provide concrete answers to the questions and problems faced by staff, based on the recommendations of reference organisations, such as WHO and UNICEF, as well as Médecins Sans Frontières’ experience in the field.
It is divided into 8 chapters. Chapter 1, Cholera overview, outlines the epidemiological and clinical features of cholera. Chapter 2, Outbreak investigation, explains the method and stages of a field investigation, from the alert to implementation of initial activities. Chapter 3, Cholera control measures, details measures and tools to prevent and/or control cholera transmission and mortality in populations affected, or at risk of being affected, by an epidemic (curative care, prevention means and health promotion activities). Chapter 4, Strategies for epidemic response, addresses the roll-out strategies of the measures described in Chapter 3 which depend on context (e.g. urban, rural, endemic, non-endemic setting, etc.), resources and particular constraints. Chapter 5, Cholera case management, details the different stages of cholera treatment, from diagnosis through to cure.
Chapter 6, Setting up cholera treatment facilities, focuses on the installation of treatment facilities that vary in size and complexity according to operational requirements (treatment centres and units and oral rehydration points). Chapter 7, Organisation of cholera treatment facilities, describes the organisation of these specialized facilities in terms of human resources, supply, water, hygiene and sanitation, etc. Chapter 8, Monitoring and evaluation, presents the key data to be collected and analysed during an epidemic to facilitate a tailored response and evaluate its quality and effectiveness.
The guide includes various practical tools in the appendices to facilitate activities (e.g. water quality tests, job descriptions, documents, etc.). Moreover, the toolbox also contains additional tools in editable formats (individual patient file, cholera case register, pictograms).
Despite all efforts, it is possible that certain errors may have been overlooked in this guide. Please inform the authors of any errors detected.
To ensure that this guide continues to evolve while remaining adapted to field realities, please send any comments or suggestions.
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