IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection
IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection
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DOI：
10.1515/cclm-2020-1412
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发表时间：
2020-12-01
影响因子：
6.8
通讯作者：
Lippi, Giuseppe
中科院分区：
文献类型：
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作者：
Bohn, Mary Kathryn;Mancini, Nicasio;Lippi, Giuseppe
全球严重急性呼吸系统综合征冠状病毒2型（SARS-CoV-2）感染的诊断广泛依赖分子检测，这对2019冠状病毒病（COVID-19）大流行期间的病例识别、隔离、接触者追踪和感染控制措施的合理化至关重要。因此，临床实验室需要验证新开发的分子检测，并以前所未有的速度增加检测能力。由于COVID-19大流行继续对全球健康构成威胁，实验室在选择、验证和解释这些检测方面继续面临挑战。本文件由国际临床化学和实验室医学联合会（IFCC）COVID-19特别工作组编写，提供了以下方面的临时指南：（A）临床适应症和目标人群，（B）检测方法选择，（C）检测方法验证，以及（D）SARS-CoV-2感染分子检测的检测结果解释和限制。这些基于证据的建议将为世界各地的临床实验室提供切实可行的指导，并强调实验室医学在我们集体应对大流行中的持续重要性。
The diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection globally has relied extensively on molecular testing, contributing vitally to case identification, isolation, contact tracing, and rationalization of infection control measures during the coronavirus disease 2019 (COVID-19) pandemic. Clinical laboratories have thus needed to verify newly developed molecular tests and increase testing capacity at an unprecedented rate. As the COVID-19 pandemic continues to pose a global health threat, laboratories continue to encounter challenges in the selection, verification, and interpretation of these tests. This document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 provides interim guidance on: (A) clinical indications and target populations, (B) assay selection, (C) assay verification, and (D) test interpretation and limitations for molecular testing of SARS-CoV-2 infection. These evidence-based recommendations will provide practical guidance to clinical laboratories worldwide and highlight the continued importance of laboratory medicine in our collective pandemic response.