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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Technical specifications for selection of essential in vitro diagnostic tests for SARS-COV-2, 14 June 2021
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. A OMS revisou o Regulamento Sanitário Internacional em 2005 “para ajudar a comunidade internacional a prevenir e a responder aos riscos agudos de saúde pública que tenham o potencial de cruzar fronteiras e ameaçar pessoas em todo o mundo”. Esses regulamentos exigem que todos os 196 estados-membros da OMS estejam bem preparados para surtos em potencial e novas doenças; isso inclui o diagnóstico precoce e a confirmação laboratorial para facilitar a prevenção e o controle de infecções.
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TECHNICAL SPECIFICATIONS FOR TEST SELECTION ESSENTIAL IN VITRO DIAGNOSTIC TESTS FOR SARS-COV-2
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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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 following protocol has been designed to investigate the First Few X cases (FFX) and their close contacts. It is envisioned that the FFX 2019-nCoV investigation will be conducted across several countries or sites with geographical and demographical diversity. Using a standardized protocol such a...s the protocol provided here, epidemiological exposure data and biological samples can be systematically collected and shared rapidly in a format that can be easily aggregated, tabulated and analyzed across many different settings globally for timely estimates of 2019-nCoV infection severity and transmissibility, as well as to inform public health responses and policy decisions. This is particularly important in the context of a novel respiratory pathogen, such as 2019-nCoV
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The purpose of this document is to provide interim guidance to laboratories and stakeholders involved in laboratory testing of patients who meet the definition of suspected case of pneumonia associated with a novel coronavirus identified in Wuhan, China.
19 March 2020
Protocol and preliminary evaluationas of Jan 17, 2020
Countries who have no testing capacity can send their samples to the WHO appointed 2019-nCoV referral laboratories for testing. National 2019-nCoV laboratories with limited experience are encouraged to send the first five positives and the first ten negative 2019-nCoV samples to their referral labor...atories for confirmation.
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En enero de 2020, el agente etiológico responsable de un grupo de casos de neumonía grave en Wuhan, China, fue identificado como un nuevo betacoronavirus (2019-nCoV), distinto del SARS-CoV y MERS-CoV (1) (2) (3). La secuencia genómica completa de este nuevo agente está disponible y se han desarr...ollado diferentes protocolos de detección, aunque aún no se han validado por completo. Sin embargo, a la luz de la posible introducción de un caso sospechoso relacionado con el 2019-nCoV en la Región de las Américas, la Organización Panamericana de la Salud / Organización Mundial de la Salud (OPS / OMS) recomienda a los Estados Miembros garantizar su identificación oportuna, el envío de las muestras a laboratorios Nacionales o de referencia y la implementación del protocolo de detección molecular para 2019-nCoV, según la capacidad del laboratorio.
Hasta la fecha, no es completamente claro el potencial patogénico ni la dinámica de transmisión del 2019nCoV. Por esta razón y a la luz del conocimiento de otros virus similares (MERS-CoV, SARS-CoV), es necesario mantener y fortalecer las medidas de bioseguridad y elementos de protección personal para el trabajo con muestras sospechosas de infección con patógenos respiratorios.
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Временные рекомендации
17 января 2020 г.
Цель настоящего документа – предоставить временные рекомендации лабораториям и субъектам, занятым в работах по лаборатор...ному тестированию пациентов в случаях, соответствующих определению подозрительных на пневмонию, ассоциированную с новым коронавирусом, выявленным в Ухане, Китай (см. Surveillance case definitions for human infection with novel coronavirus, Interim guidance (Эпиднадзор за случаями инфекции человека, вызванной новым коронавирусом, временные рекомендации (на английском языке)).
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For SARS-CoV-2 testing only
Timely detection of novel coronavirus (2019-nCoV) infection cases is crucial to interrupt the spread of this virus. We assessed the required expertise and capacity for molecular detection of 2019-nCoV in specialised laboratories in 30 European Union/European Economic Area (EU/EEA) countries. Thirty-...eight laboratories in 24 EU/EEA countries had diagnostic tests available by 29 January 2020. A coverage of all EU/EEA countries was expected by mid-February. Availability of primers/probes, positive controls and personnel were main implementation barriers.
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Временное руководство
19 марта 2020 г.
Данный документ предоставляет временное руководство лабораториям и заинтересованным сторонам, участвующим в лабораторном ...естировании пациентов с вирусом COVID-19.
Документ частично основан на временном руководстве по лабораторному тестированию на коронавирус, вызывающий ближневосточный респираторный синдром (MERS).1-6 Информация о заражении человека вирусом COVID-19 постоянно обновляется, ВОЗ продолжает следить за развитием событий и по необходимости пересматривать рекомендации.
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