Effective malaria case management requires quick access to diagnostics and antimalarial treatments to reduce illness and death. Artemisinin-based combination therapy (ACT) has been essential to malaria treatment since 2001, as it combines artemisinin for rapid parasite reduction with a partner drug ...to ensure complete cure. However, resistance to antimalarial drugs, where parasites survive standard doses, threatens malaria control.
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8 January 2021
Sequencing enabled the world to rapidly identify SARS-CoV-2 and develop diagnostic tests and other tools for outbreak management. Continued genome sequencing supports the monitoring of the disease’s spread and evolution of the virus. Accelerated integration of genome sequencing int...o the practices of the global health community is required if we want to be better prepared for the future threats. This document provides guidance for laboratories on maximizing the impact of SARS-CoV-2 sequencing now and other emerging pathogens in the future.
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The goals of Ebola virus disease (EVD) surveillance during Phase 3 of the Ebola response are to promptly detect new, suspected EVD cases and deaths so as to trigger appropriate response, including rapid diagnosis, case isolation and management, contact tracing, safe burials, and the identification o...f transmission chains
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The recommendations in these guidelines promote the use of simple, non-invasive diagnostic tests to assess the stage of liver disease and eligibility for treatment; prioritize treatment for those with most advanced liver disease and at greatest risk of mortality; and recommend the preferred use of n...ucleos(t)ide analogues with a high barrier to drug resistance (tenofovir and entecavir, and entecavir in children aged 2–11 years) for first- and second-line treatment. Recommendations for the treatment of HBV/HIV-coinfected persons are based on the WHO 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection, which will be updated in 2015.
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This policy guideIine is intended for use by healthcare professionals invoIved in the management of Covid-19 in South Africa. The document provides guidance on diagnostic tests available, on antigen test performance and accessibility. 1t focuses on key issues such as when to
Perform antigen tests... how to use and interpret results. Capturing and reporting testing information is also covered.
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this toolkit presents a structured, rating-based methodology designed to provide a rapid, comprehensive assessment of the capacity of the human resource support system for a country’s supply chain. Data are gathered from a document review, focus group discussions, and in-country stakeholder interv...iews to identify the strengths, areas for improvement, opportunities, and challenges for a wide range of human resource inputs and components. The findings are transformed into specific recommendations and strategies for action based on an understanding of country priorities and programming gaps. It includes Word templates; PowerPoint templates and Exce-based Diagnostic Dashboard
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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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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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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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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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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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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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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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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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Available in Arabic, Chinese, English, French, Portuguese, Russian and Spanish
https://apps.who.int/iris/handle/10665/334254
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 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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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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