Entretanto, à luz da possível introdução de um caso suspeito relacionado ao COVID-19 na Região das Américas, a Organização Pan-Americana da Saúde/Organização Mundial da Saúde (OPAS/OMS) recomenda que os Estados-membros garantam sua identificação oportuna, o envio de amostras a laborat...rios nacionais ou de referência e a implementação do protocolo de detecção molecular do COVID-19, dependendo da capacidade do laboratório. Até à data, o potencial patogênico e a dinâmica de transmissão do COVID-19 não são completamente claros. Por esta razão e à luz do conhecimento de outros vírus semelhantes (MERS-CoV, SRA-CoV), é necessário manter e reforçar as medidas de biossegurança e os equipamentos de proteção individual para o trabalho com amostras suspeitas de infecção com patógenos respiratórios.
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Many in-house and commercial assays that detect the COVID-19 virus have been developed or are currently under development. Many of these molecular assays are currently being validated in partner laboratories. An overview of assays that have applied to FIND for participation in their assay assessment... work can be found here
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O objetivo deste documento é fornecer orientações provisórias de biossegurança laboratorial para testes com amostras clínicas de pacientes que atendam à definição de casos do novo patógeno identificado em Wuhan, China, ou seja, a doença do coronavírus 2019 (COVID-19). A OMS revisará ess...as recomendações conforme necessário.
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Protocol and preliminary evaluationas of Jan 17, 2020
User Guide.
This Laboratory Assessment Tool (LAT) is specifically designed to assess capacities of existing laboratories which have implemented or aim to implement SARS-CoV-2 testing. It addresses both core capacities of a laboratory and specificities related to SARS-CoV-2 testing. It is a focused... and shorter version from the existing complete laboratory assessment tool that can be found at https://www.who.int/ihr/publications/laboratory_tool/en/
The target audience is any stakeholder performing laboratory assessments such as national health authorities, multilateral agencies, Non-Governmental Organizations (NGOs) and laboratory managers. Assessors can use the tool, and customized if needed, to meet local requirements or assessment context. This tool is an Excel file, which enables automatic calculations of module indicators.
https://www.who.int/publications/i/item/laboratory-assessment-tool-for-laboratories-implementing-covid-19-virus-testing
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This document provides brief information answering common questions regarding COVID-19 diagnostic tests and how to prioritize them to the patients most in need.
В этом документе представлены временные рекомендации для лабораторий и других заинтересованных сторон,
принимающих участие в диагностической работе для выявлен...ия коронавируса тяжелого острого респираторного
синдрома – 2 (SARS-CoV-2). В нем освещены основные соображения касательно взятия биологических образцов,
применения методов амплификации нуклеиновых кислот (МАНК), определения антигенов (Аг) и антител (Ат), а также
обеспечения качества.
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Tests zur Detektion einer Infektion mit SARS-CoV-2 (neuartiges Coronavirus) sowie zum Nachweis von Antikörpern gehören zu den sog. In-vitro-Diagnostika (IVD). Das erstmalige Inverkehrbringen von In-vitro-Diagnostika auf dem deutschen Markt ist nach §§ 25 und 30 Medizinproduktegesetz (MPG) anzeig...epflichtig. Das DIMDI betreibt dafür die Datenbank "In-vitro-Diagnostika-Anzeigen (MPIVDA)", in welcher demnach auch Daten von "Corona-Tests" von den anzeigepflichtigen deutschen Herstellern und Bevollmächtigten bzw. Einführern erfasst werden.
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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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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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