In vitro diagnostic medical device regulation (IVDR): the end of laboratory developed tests (LDT)?
作者信息
Barberis Massimo
机构信息
Clinic Unit Histopathology and Molecular Diagnostics, European Institute of Oncology, IRCCS, Milano, Italy.
出版信息
Pathologica. 2021 Apr;113(2):68-69. doi: 10.32074/1591-951X-237. Epub 2021 Mar 18.
Abstract
摘要
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The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications.我们所熟知的实验室自行开发检测的终结？一个由实验室专家组成的全国多学科特别工作组关于体外诊断医疗器械法规（IVDR）解读及其并发症的建议
Clin Chem Lab Med. 2020 Nov 23. doi: 10.1515/cclm-2020-1384.
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Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century!医学检验的计量溯源与协调：在21世纪，需要实现巨大飞跃才能跟上全球化步伐并符合严格的体外诊断医疗器械法规！
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