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How the European in vitro diagnostic regulation could negatively impact the European response to the next pandemic: an urgent call for action before May 2022.

作者信息

Vermeersch Pieter, André Emmanuel

机构信息

Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.

Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.

出版信息

Clin Microbiol Infect. 2021 Aug;27(8):1074-1075. doi: 10.1016/j.cmi.2021.05.009. Epub 2021 May 9.

DOI:10.1016/j.cmi.2021.05.009
PMID:33979703
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8106968/
Abstract
摘要

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本文引用的文献

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Testing in a Pandemic - Improving Access, Coordination, and Prioritization.疫情期间的检测——改善可及性、协调性和优先级
N Engl J Med. 2021 Jan 21;384(3):197-199. doi: 10.1056/NEJMp2025173. Epub 2021 Jan 16.
2
The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care.2017/746 号新体外诊断法规：比利时一家大型大学医院实验室的案例研究表明，有必要明确实验室在使用实验室自建检测以改善患者护理方面的自由度。
Clin Chem Lab Med. 2020 Jul 21;59(1):101-106. doi: 10.1515/cclm-2020-0804.
3
Lessons from the Belgian experience with regulatory control during the COVID-19 pandemic for the implementation of the European IVD regulation 2017/746.比利时在新冠疫情期间实施监管控制的经验对欧洲体外诊断医疗器械法规2017/746实施的借鉴意义。
Acta Clin Belg. 2022 Feb;77(1):1-3. doi: 10.1080/17843286.2020.1787659. Epub 2020 Jul 2.
4
Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries, January 2020.2020 年 1 月，30 个欧盟/欧洲经济区国家的专家实验室对新型冠状病毒（2019-nCoV）的实验室准备和应对情况。
Euro Surveill. 2020 Feb;25(6). doi: 10.2807/1560-7917.ES.2020.25.6.2000082. Epub 2020 Feb 11.
5
Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR.实时 RT-PCR 检测 2019 新型冠状病毒（2019-nCoV）
Euro Surveill. 2020 Jan;25(3). doi: 10.2807/1560-7917.ES.2020.25.3.2000045.