Second Edition
AIDS Medicines and diagnostics services
July 2015
4th edition
The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.
LBM encouraged countries t...o accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety.
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The aim of this handbook is to provide network members and other laboratories involved in the diagnosis of tuberculosis, with an agreed list of key diagnostic methods and their protocols in various areas of TB diagnosis, ranging from microbiological diagnosis of active TB to the diagnosis of latent ...TB infection. This handbook offers a single source of reference by compiling all methods, with a strong focus on standard (reference) and evidence-based methods. In so doing, it will also contribute to the improvement of disease surveillance data for Europe.
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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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Комплект учебных материалов по Xpert MTB/RIF
The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to nee...d (e.g. basic users, supervisors, clinicians). Topics covered include: Overview of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
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The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to need (e.g. basic users, supervisors, clinicians). Topics covered include: Over...view of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
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The modules (1-12) are based on materials originally developed by FIND, KNCV and Cepheid, and are in PowerPoint format for country customization. Depending on the audience, modules may be selected and adapted according to need (e.g. basic users, supervisors, clinicians). Topics covered include: Over...view of TB and diagnostics, biosafety, specimen collection, procurement, installation, Xpert MTB/RIF technology, results interpretation, reporting, troubleshooting, maintenance, a clinical guide, and quality assurance.
Please download each manual directliy from the website
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The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerat...ions, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
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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 and preparedness to generate a prompt and effective response in the event of an emergency. Th...e 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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Prequalification of Male Circumcision Devices
PQMC_007 v1 16 December 2011
Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-gamma release assays (IGRA) are also valid for Beij...ing Wantai’s TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in this WHO policy statement.
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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 public health threats. Genomic surveillance is part of the broader surveillance and laboratory system, a...nd 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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The Committee discussed the implications for preparedness for smallpox-like events reflected by the ongoing COVID-19 pandemic. The Committee noted how quickly diagnostics and vaccines could be developed and deployed when resources and political will were abundant. This rapidity was also due to the f...act that the genetic sequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had been shared worldwide. It was noted that in one country SARS-CoV-2 had been reconstructed in a laboratory from the viral genome sequence before the first case of COVID-19 had been reported, highlighting the benefits of synthetic biology technologies for accelerated development of diagnostics as well as the oft-described potential risks. Lessons learned about clinical care during the COVID-19 pandemic were also discussed.
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Biosensors and Bioelectronics: X Volume 10, May 2022, 100100; This article provides an overview of dengue disease, the working principles, the significance of the various conventional and biosensor detection strategies, the benefits and problematic conditions of the reported methods. The present hu...rdles of transferring laboratory research into real-world technological implementations and the future possibilities for detecting devices for viral diagnosis are highlighted in this study.
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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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This analysis focused on the chronic form of HAT caused by T. b. gambiense, as it contributes to the majority of disease burden. Information from the literature review,
product development landscape, and stakeholder interviews was compiled to:
- Identify use cases and understand current diagnosti...c practices and tools associated with each use case.
- Analyze progress toward robust diagnostics for HAT across different biomarkers.
- Develop recommendations for steps to improve the availability, access, and adoption of HAT diagnostic tools.
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Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria. This analysis overviews landscape analyses of point-of-care diagnostic technologies for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vagi...nalis and syphilis, available and in the pipeline. The target audience for the target product profiles is broad and includes clinicians, researchers working on diagnostics, laboratory experts, including, microbiologists and virologists, public health experts, epidemiologists, developers, and representatives for manufactures, including biotech engineers, policy-and decision-makers as well as representatives from regulatory bodies and agencies, donor agencies and international organizations.
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