The purpose of this document is to provide interim guidance to laboratories and stakeholders involved in laboratory testing for Middle East respiratory syndrome coronavirus (MERS-CoV).
"Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to eng...age in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents"--Page 7.
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This document updates recommendations for HIV testing by laboratories in the United States and offers approaches for reporting test results to persons ordering HIV tests and to public health authorities. The recommended algorithm is a sequence of tests used in combination to improve the accuracy of ...the laboratory diagnosis of HIV based on testing of serum or plasma specimens. The updated recommendations also include tests for HIV antigens and HIV nucleic acid because studies from populations at high risk for HIV demonstrate that antibody testing alone might miss a considerable percentage of HIV infections detectable by virologic tests
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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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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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Septième (7ème) édition de la liste nationale des médicaments essentiels, cinquiême (5ème) édition de la liste nationale des produits pharmaceutiques d'urgence, quatrième (4ème) édition de la liste nationale des réactifs essentiels pour l'analyses de biologie médicale.
La présente é...dition épouse les différents niveaux de laboratoires, aux produits d'urgence, aux médicaments vitaux pour la mère et l'enfant et aux dispositifs utilisés en Odontostomatologie.
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The purpose of this document is to provide guidance on the use of pooled sample testing strategy in coronavirus disease (COVID-19)
testing laboratories of the African Union Member States for scaling up SARS-CoV-2 nucleic acid testing capacity with the available resources. The current document descr...ibes the effect of factors such as the prevalence of COVID-19 in the population to be tested, the homogeneity of pools, and the sensitivity of the molecular test in optimal pool size determination. It also highlights the importance of monitoring the prevalence of COVID-19 in a population to be tested and proper validation of the test, to limit the potential for false-negative results. Validation studies to determine the optimal pool size by testing laboratories are recommended as the optimum approach. A safe, simple ‘two-stage pooling’ option has been indicated in this guidance to be used by laboratories until such validation can be achieved.
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Sequencing SARS-CoV-2 in the Americas
The COVID-19 Genomic Surveillance Regional Network was created in 2020 not only to strengthen the sequencing capacity in the participating laboratories, but also for them to establish a routine SARS-CoV-2 genomic sequencing, as a strategy to increase the amoun...t of genetic sequence data available to the global community, which is critical to support the development of diagnostic protocols, the information for vaccine development and to better understand the evolution and molecular epidemiology of the SARS-CoV-2.
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El manual detalla los procedimientos más apropiados para el diagnóstico de los enteroparásitos descritos en nuestro medio y se espera que sea una ayuda inmediata para el personal técnico y profesional de los laboratorios locales, intermedios y regionales de la Red Nacional de Laboratorios en Sal...ud Pública del país.
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El manual está orientado para dar a conocer las directrices y métodos para evaluar la calidad y confiabilidad de las baciloscopías que realizan los laboratorios. Aunque estos métodos o están concebidos para verificar el diagnóstico de cada paciente, el procedimiento de identificar y corregir l...os problemas observados en los laboratorios servirá para asegurar la calidad de los servicios de diagnóstico. Es por ello que la garantía o aseguramiento de la calidad de los laboratorios que realizan baciloscopías a partir de esputos, es esencial.
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El manual da a conocer los procedimientos técnicos de evaluación externa de la calidad de los medios de cultivo sólido Ogawa y Lowestein Jensen, preparados en los laboratorios de la red nacional de tuberculosis.
In 2009, WHO’s Second International Conference on Buruli Ulcer Control and Research resolved to strengthen the capacity of national laboratories to confirm cases of the disease, but advised that “efforts are still needed to develop simple diagnostic tools usable in the field as well as disabilit...y prevention methods”.
In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
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El presente documento contiene los requisitos mínimos necesarios para el trabajo seguro en la red de laboratorios de TB del país, de acuerdo a las directrices emanadas del Laboratorio de Referencia Nacional de TB, correspondiente a la Sección Micobacterias en el Instituto de Salud Pública.
La ...estructura de la red de laboratorios se muestra en la siguiente tabla, con distintas denominaciones de acuerdo al criterio empleado para categorizarlos.
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Any individual that meets the suspected case definition of monkeypox should be offered testing in appropriately equipped laboratories by staff trained in the relevant technical and safety procedures. Confirmation of monkeypox virus infection is based on nucleic acid amplification testing (NAAT), usi...ng real-time or conventional polymerase chain reaction (PCR), for detection of unique sequences of viral DNA. PCR can be used alone, or in combination with sequencing. The recommended specimen type for laboratory confirmation of monkeypox is skin lesion material, including swabs of lesion surface and/or exudate, roofs from more than one lesion, or lesion crusts.
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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.
The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit...h the recommendations of the WHO Laboratory Biosafety Manual 4th edition (LBM4), adopting an evidence- and risk-based approach to enable scalable and adaptable biosafety provisions and actions, proportionate to the assessed risk
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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.
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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Africa CDC Institute of Pathogen Genomics (IPG) was launched in November 2019 and operates under the Division of Laboratory Systems and Networks.
IPG coordinate the implementation of molecular diagnostics, pathogen genomics and bioinformatics in National Public Health Institutions (NPHIs) and/or Re...fe-
-rence Laboratories (NRLs) across Africa.
Africa CDC and APHF are coordinating a continental initiative to maximize the benefits of molecular approaches and pathogen genomics for more effective
outbreak preparedness, prevention, response, and for the control and elimination of endemic diseases in Africa. One of Africa CDC’s flagship initiative is the Africa
Pathogen Genomics Initiative (Africa PGI), a partnership that aims to strengthen laboratory systems and enhance genomic surveillance by equipping the continent’s
public health institutions with the tools, training, and data infrastructure.
About the Project
In 2023, 166 outbreaks and public health events were reported in Africa. This calls for a resilient laboratory systems for timely detection and reporting of current and future outbreaks. This project aims to scale up molecular diagnostic and genomic sequencing-based detection and characterization of outbreaks.
Africa CDC is working with Member States to develop guidance, diagnostic algorithm, training and capacity building to enable outbreak detection, and reporting to inform public health response.
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