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评估六种商业化的 SARS-CoV-2 快速抗原检测试剂盒在鼻咽拭子样本中的应用:更好的知识是否有助于更好地管理患者?

Evaluation of six commercial SARS-CoV-2 rapid antigen tests in nasopharyngeal swabs: Better knowledge for better patient management?

机构信息

Univ. Grenoble Alpes, Laboratoire de Virologie, Centre Hospitalier Universitaire (CHU) Grenoble - Alpes, 38000 Grenoble, France; Institut de Biologie Structurale (IBS), University Grenoble Alpes, CEA, CNRS, 38000 Grenoble, France.

Univ. Grenoble Alpes, Laboratoire de Virologie, Centre Hospitalier Universitaire (CHU) Grenoble - Alpes, 38000 Grenoble, France.

出版信息

J Clin Virol. 2021 Oct;143:104947. doi: 10.1016/j.jcv.2021.104947. Epub 2021 Aug 20.

Abstract

Robust antigen point-of-care SARS-CoV-2 tests have been proposed as an efficient tool to address the COVID-19 pandemic. This requirement was raised after acknowledging the constraints that are brought by molecular biology. However, worldwide markets have been flooded with cheap and potentially underperforming lateral flow assays. Herein we retrospectively compared the overall performance of five qualitative rapid antigen SARS-CoV-2 assays and one quantitative automated test on 239 clinical swabs. While the overall sensitivity and specificity are relatively similar for all tests, concordance with molecular based methods varies, ranging from 75,7% to 83,3% among evaluated tests. Sensitivity is greatly improved when considering patients with higher viral excretion (Ct≤33), proving that antigen tests accurately distinguish infectious patients from viral shedding. These results should be taken into consideration by clinicians involved in patient triage and management, as well as by national authorities in public health strategies and for mass campaign approaches.

摘要

稳健的抗原即时检测 SARS-CoV-2 检测方法已被提议作为应对 COVID-19 大流行的有效工具。这一需求是在认识到分子生物学带来的限制后提出的。然而,全球市场充斥着廉价且可能表现不佳的侧向流动检测。在此,我们回顾性比较了五种定性快速抗原 SARS-CoV-2 检测方法和一种定量自动化检测方法在 239 份临床拭子上的总体性能。虽然所有检测方法的总体敏感性和特异性都相对相似,但与基于分子的方法的一致性存在差异,评估的检测方法之间的一致性在 75.7%到 83.3%之间。当考虑到病毒排泄量较高的患者(Ct≤33)时,敏感性会大大提高,这证明抗原检测可以准确区分具有传染性的患者和病毒脱落的患者。这些结果应引起参与患者分诊和管理的临床医生以及公共卫生策略和大规模宣传方法的国家当局的关注。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae78/8376530/e932100f0105/gr1_lrg.jpg

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