IFCC Interim Guidelines on Serological Testing of Antibodies against SARS-CoV-2
IFCC Interim Guidelines on Serological Testing of Antibodies against SARS-CoV-2
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DOI：
10.1515/cclm-2020-1413
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发表时间：
2020-12-01
影响因子：
6.8
通讯作者：
Adeli, Khosrow
中科院分区：
文献类型：
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作者：
Bohn, Mary Kathryn;Loh, Tze Ping;Adeli, Khosrow
用于检测严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）抗体的血清学检测正在成为2019冠状病毒病（COVID-19）患者临床管理以及全球SARS-CoV-2暴露流行病学评估的重要组成部分。除了检测SARS-CoV-2感染的分子检测外，临床实验室还需要增加检测能力，以包括对疑似或已知COVID-19患者的血清学评估。虽然监管批准的血清学免疫测定法目前可从全球诊断制造商广泛获得，但关于这些检测的临床实用性以及应用前的临床和分析性能要求存在重大争议。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）检测方法评价，以及（D）SARS-CoV-2感染抗体血清学检测的检测解释和限制。这些基于证据的建议将为临床实验室在选择、验证和实施血清学检测方面提供实用指导，并且在我们将大流行应对措施从最初的病例追踪和遏制扩大到缓解策略以最大限度地减少复发和进一步的发病率和死亡率时至关重要。
Serological testing for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is emerging as an important component of the clinical management of patients with coronavirus disease 2019 (COVID-19) as well as the epidemiological assessment of SARS-CoV-2 exposure worldwide. In addition to molecular testing for the detection of SARS-CoV-2 infection, clinical laboratories have also needed to increase testing capacity to include serological evaluation of patients with suspected or known COVID-19. While regulatory approved serological immunoassays are now widely available from diagnostic manufacturers globally, there is significant debate regarding the clinical utility of these tests, as well as their clinical and analytical performance requirements prior to application. This document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Taskforce on COVID-19 provides interim guidance on: (A) clinical indications and target populations, (B) assay selection, (C) assay evaluation, and (D) test interpretation and limitations for serological testing of antibodies against SARS-CoV-2 infection. These evidence-based recommendations will provide practical guidance to clinical laboratories in the selection, verification, and implementation of serological assays and are of the utmost importance as we expand our pandemic response from initial case tracing and containment to mitigation strategies to minimize resurgence and further morbidity and mortality.