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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For several years, agencies supporting preparedness and response to cholera outbreaks have supplied medicines and medical devices through the Interagency Diarrhoeal Disease Kits (IDDK).
In an effort to better align the presentation and content of the kits to field needs, the composition of the ch...olera kits has been reviewed by WHO and its partners in 2015 and again in 2020. The content of all modules have been slightly revised with no changes except for the cholera laboratory check list.
The revised cholera kits 2020 are designed to help prepare for a potential cholera outbreak and to support the first month of the initial response for 100 cases. The overall package consists of six different kits, each divided in several modules.
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A manual for health care providers.
This manual provides expert guidance on the laboratory techniques and procedures used in the diagnosis of Buruli ulcer, a disease caused by Mycobacterium ulcerans. Aimed at laboratory technicians and scientists working on this disease, the manual details the exac...t procedures to follow when performing a range of diagnostic tests. Recommended procedures, intended for use throughout the health system, are presented at levels appropriate for peripheral, district and central services and in accordance with the varying resources, skills and equipment typically found in countries where Buruli ulcer is endemic.
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Manuel destiné au personnel de santé. Le présent manuel est un guide spécialisé sur les techniques et les méthodes de laboratoire à utiliser pour le diagnostic de l’ulcère de Buruli, une maladie provoquée par Mycobacterium ulcerans. Destiné aux techniciens et aux scientifi ques de labora...toire travaillant sur cette maladie, le présent manuel décrit les méthodes exactes à mettre en oeuvre pour réaliser un certain nombre de tests diagnostiques. Les procédures recommandées, utilisables dans l’ensemble du système de santé, sont adaptées aux services périphériques, des districts et centraux et ce, conformément aux ressources, compétences et matériel variables que l’on trouve classiquement dans les pays où l’ulcère de Buruli est endémique.
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A total of 18 laboratories from 13 countries participated in the four rounds of EQA: 10 laboratories from eight African endemic countries, four of which participated in all four rounds and three in three rounds. The overall results showed that the median performance of these laboratories improved ov...er the four rounds. However, the proportion of laboratories reporting false–positive cases remains high and indicates a problem of specificity probably due to contamination. The proportion of laboratories reporting both false–positive and false–negative results raises the issue of the quality of the data reported by WHO in Africa as well as the results of the studies carried out in these different laboratories in various countries.
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he Framework sets the requirements for facilities handling High Consequence Agents and Toxins (HCATs) and guides the implementation of laboratory biosafety and biosecurity practices associated with the design, commissioning, routine operation safe and secure biocontainment laboratories.
Quarta Edição.
Esta quarta edição do manual se baseia no esquema de avaliação de risco apresentado na terceira edição. Uma avaliação completa, baseada em evidências e transparente dos riscos permite que as medidas de segurança sejam equilibradas com o risco real de trabalhar com agentes... biológicos, caso a caso. Isso permitirá que os países implementem políticas e práticas de biossegurança e biosseguridade laboratoriais economicamente viáveis e sustentáveis que sejam relevantes para suas circunstâncias e prioridades individuais.A necessidade de atualizar as diretrizes de biossegurança de laboratórios internacionais faz parte de uma iniciativa mais ampla para globalizar a biossegurança e enfatizar os princípios e as abordagens que são acessíveis a países que tenham ampla gama de recursos financeiros, técnicos e regulatórios
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This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
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To meet the need for laboratory diagnosis to be integrated in community care, the new 2022 Update describes point-of-care tests that can be performed both in district laboratories and peripheral healthcare facilities by non-specialist staff. Also included are recently developed self-tests.
The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the M...UL_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
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The World Health Organization’s (WHO) global report for the year 2019 indicates that sub-Saharan Africa (SSA) has a very high maternal mortality rate (MMR) with a 2017 point estimate of 542 (UI 498 to 649) maternal deaths per 100 000 live births, accounting for approximately 66% of estimated globa...l maternal deaths. Despite recent improvements, current analysis confirms that millions of mothers and children are still dying every year because of severe anaemia due to insufficient blood supply. The lack of blood to treat severe perinatal haemorrhage contributes to up to 72% of maternal deaths (2,3). Similarly, delayed transfusion has been associated with increased infant mortality in cases of paediatric malaria-associated anaemia (4,5). Indeed, safe and reliable blood and blood products remain unavailable to many people living in the world’s poorest countries, particularly in SSA. While the need for blood is universal, there is a significant imbalance between developing and industrialized countries accessing safe blood.
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Dengue is a significant public health problem. There are four dengue virus serotypes identified; however, its diagnosis is difficult due to the existence of many viruses, bacteria, and parasites producing the same clinical presentation, being present in the same geographical area and even producing ...coinfections. Therefore, determining whether a person has, had, or is infected with dengue virus is of great importance. In order to do so, direct and indirect laboratory tests have been developed to identify the virus or part of its structure that generally detects the antibody response. These techniques are used for diagnosis, epidemiological studies, monitoring, assessment and production of vaccines and antivirals, etc. They range from the use of cell cultures, animal models, inoculation by insects, and serology tests to the use of detection molecular tests and quantification of genetic material that are described in this chapter herein, a brief explanation of this methodology, its strengths and weaknesses, and its application in the dengue research.
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Little progress has been made since the 1960s and 1970s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and operational challenges in the clinica...l drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
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Leishmaniasis is a spectrum of disease caused by the infection of protozoan parasite Leishmania mainly affecting the antigen presenting cell of the host. The disease is although considered as neglected tropical disease still it is not completely eradicated. Majority of the issues related to the ther...apeutic approach is due to increased cytotoxicity of the drugs, less effectiveness, high cost and occurrence of drug resistance. Therefore, recent advancement in the field of parasitology has taken into consideration of the specific arms of immunity which can be triggered with the help of natural products, synthetic molecules or parasite specific ligands which helps in the restoration of host protective immunity and recovery from the infection. Therefore, in this review, we have highlighted the recent advancement in the field of Leishmania research taken into consideration of the therapeutic perspective. We have shown that apart from therapeutic potential of the available drugs and vaccination approach, the immune-therapy are emerging as the modern regime of treatment where the effectiveness of the therapy is significantly increased and making it safer and promising.
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Through the USAID-funded Organized Network of Services for Everyone’s Health (ONSE) Activity, MSH is assisting Malawi’s National Malaria Control Program to provide high-quality malaria services at the facility and community levels in 10 districts, covering nearly a third of the country.
Our ...team in Malawi share recent results on strengthening malaria services through Outreach Training and Supportive Supervision (OTSS).
Designed to provide ongoing support to clinicians, data, and laboratory staff, OTSS combines a standardized checklist with targeted mentorship and supportive supervision to identify areas for improvement and strengthen clinical and diagnostic services in health facilities.
This webinar shares lessons learned on how the application of OTSS, as part of broader quality assurance systems, impacts staff performance and improves the provision and quality of malaria services.
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This document provides detailed guidance on laboratory testing for suspected diphtheria cases during significant outbreaks or in low-resource settings. It aims to supplement and build on other existing WHO guidance documents on surveillance standards, diagnostics and research on Corynebacterium by p...roviding key considerations for laboratories that allow the rationalization and optimization of testing during outbreaks. The recommendations given here have been prepared by WHO in consultation with, and reviewed by, global experts with experience in laboratory analysis of Corynebacterium species and in outbreak settings, or with expertise in developing new technologies for diphtheria research and diagnosis. Unless otherwise stated, the considerations provided apply to diphtheria outbreaks caused by toxin-producing C. diphtheriae with a classical respiratory diphtheria presentation.
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This operational guide addresses important infection prevention and control (IPC) measures that should be implemented during a diphtheria outbreak and primarily addresses respiratory Corynebacterium diphtheriae (C. diphtheria).
Anaemia is a global public health concern, especially afflicting adolescent girls, women 15–49 years of age, pregnant women, and children in low- and middle-income countries. WHO estimates that in 2019 30% (571 million) of women aged 15–49 years, 37% (32 million) of pregnant women, and 40% (269 ...million) of children 6–59 months of age were affected by anaemia, with the WHO African Region and South-East Asia
Region being most affected(
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