"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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Actualités et réflexions sur la prise en charge médicale du premier patient suspect d’infection par le premier médecin
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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Vol. 2: Clinicians' Guide
Clinicians’ Guide is designed to assist busy medical practitioners in the field with patient management by providing current, essential, practical guidance and background, packaged into a single resource
WHO guidelines on the pharmacological treatment of persisting pain in children with medical illnesses
This resource consists of technical guidelines for District Medical Officers, counselors and laboratory technicians for second-line antiretroviral therapy drugs, operational guidelines for pilot roll-out in two centres and laboratory guidelines for viral-load testing and standard operating procedure...s.
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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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This National Action Plan addresses actions needed to be taken in order to combat antimicrobial resistance (AMR) in the country. It is obligatory to raise awareness of antimicrobial resistance and promote behavioral change through public communication
programmes that targets human, animal and plant... health. Inclusion of the use of antimicrobial agents and resistance in school curricula will further promote better understanding and awareness from an early age. Antimicrobial Resistance knowledge, surveillance and research will be strengthened through establishing a national surveillance system for antimicrobial resistance, establishing and building capacity for a national reference laboratory and designated laboratories for AMR surveillance, developing a national research agenda on AMR and establishing and supporting a coordinated mechanism that will ensure harmonized AMR guidelines, data management and sharing systems in human, animal and plant health settings.
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Republic of India (hereinafter the Recipient) willimplement the Covid-19 Emergency Response and Health Systems Preparedness project (the Project), with the involvement of the following Ministries/Agencies/Units: Ministry of Health and Family Welfare (MoHFW), Indian Council of Medical Research (ICMR)... and the National Center for Disease Control (NCDC).The International Bank for Reconstruction and Development (hereinafter the Bank) has agreed to provide financingfor the Project.
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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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doi: https://doi.org/10.1101/2020.10.28.20221143
This article is a preprint and has not been peer-reviewed [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.
Antimicrobial resistance (AMR) surveillance plays an important role in the early detection of resistant strains of public health importance and prompt response to outbreaks in hospitals and the community. Surveillance findings are needed to inform medical practice, antibiotic stewardship, and policy... and interventions to combat AMR. Appropriate use of antimicrobials, informed by surveillance, improves patients’ treatment outcomes and reduces the emergence and spread of AMR. This protocol describes the steps and procedures to establish/enhance AMR surveillance in Latin America and the Caribbean.
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The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in... 1948 recognized the need to establish a procurement service at WHO, and recommended setting up an office “to give advice on the procurement of essential drugs, biological products and other medical supplies”.
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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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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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The purpose of this book is to provide an overview of Buruli ulcer (Mycobacterium ulcerans infection) for the medical and scientific communities and the general public alike.
Snakebite is an acute life threatening time limiting medical emergency. It is a preventable public
health hazard often faced by rural population in tropical and subtropical countries with heavy
rainfall and humid climate.
The greatest risk to persons engaging in international medical emergency response is poor preparation.
The In Control handbook hopes to provide a remedy.
At the time of writing, we are living through the Coronavirus (COVID-19) pandemic, a health emergency that disregards physical borders, brin...gs into focus social inequalities and affects people on every continent. This shared challenge requires unprecedented measures and the collaboration of the brightest minds to support global health protection through this crisis and beyond. Healthcare infrastructures have to be strengthened, public health capacities and processes upgraded, medical countermeasures and vaccinations found and psychosocial side-effects treated.
Solidarity is the normative order of the day and the human species has to collaborate to face this invisible threat. Hiding and living in fear is not an option in this interconnected world. We have both a responsibility and an opportunity to make substantial contributions to a safer, healthier and more sustainable future for us all.
The existence of this handbook is an impressive example of solidarity. Over 50 authors from more than 15 institutes and organisations have come together voluntarily within a very short time to make their expertise available and enable cross-sectoral thinking. Knowledge is bundled, resources are combined, information gaps are filled. The In Control handbook is not a theoretical treatise of possible dangers, but a collection of subject-matter expertise, written by experts and practitioners who have shaped health topics over the past 20 years in the most diverse corners of the world.
The Centre for International Health Protection at the Robert Koch Institute (RKI) is collaborating with its partners and investing heavily in the build-up of operational know-how and capacity to support health crisis response abroad. This is done by preparing and enabling professionals to deploy safely across the world to assist those in need. In Control addresses the multi-faceted challenges of an international deployment. Readers will find not only technical medical information, but also insights into, for example, the fragility of our environment, the cultural differences that influence risk communication or the dilemmas arising from social distancing. Legal principles are highlighted, along with ethical guidance to ensure that our actions and decisions correspond to the highest moral standards.
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