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用于检测 SARS-CoV-2 奥密克戎变异株 BA.2 亚谱系的快速抗原检测试剂盒的分析灵敏度。

Analytical sensitivity of the Rapid Antigen Test kits for detection of SARS-CoV-2 Omicron variant BA.2 sublineage.

机构信息

Microbiology Division, Public Health Laboratory Services Branch, Department of Health, Centre for Health Protection, Hong Kong Special Administrative Region, Kowloon, Hong Kong.

出版信息

J Med Virol. 2022 Oct;94(10):5033-5037. doi: 10.1002/jmv.27908. Epub 2022 Jun 10.

Abstract

The severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) Omicron was classified as a variant of concern in November 2021. The sublineage BA.2 spreads rapidly worldwide. Currently, there is a lack of data for the parallel comparison of Rapid Antigen Test (RAT) Kits to detect SARS-CoV-2 Omicron BA.2. We evaluated the analytical sensitivity of 12 RAT kits to detect Omicron BA.2 in the present study. Analytical sensitivity was determined by means of the limit of detection (LOD). We prepared a dilution set using a respiratory specimen collected from a COVID-19 patient infected by Omicron BA.2. The reverse transcription-polymerase chain reaction was used as a reference method. The LOD results showed that all 12 RAT kits had comparable analytical sensitivity to detect Omicron BA.2. The RAT kits selected in the current study may be used for the first-line screening of the rapid spreading Omicron BA.2.

摘要

严重急性呼吸综合征冠状病毒 2 型(SARS-CoV-2)奥密克戎于 2021 年 11 月被归类为关注变体。亚系 BA.2 在全球范围内迅速传播。目前,缺乏用于平行比较快速抗原检测(RAT)试剂盒以检测 SARS-CoV-2 奥密克戎 BA.2 的数据。本研究评估了 12 种 RAT 试剂盒检测奥密克戎 BA.2 的分析灵敏度。分析灵敏度通过检测限(LOD)确定。我们使用从感染奥密克戎 BA.2 的 COVID-19 患者采集的呼吸道标本制备了稀释集。逆转录-聚合酶链反应被用作参考方法。LOD 结果表明,所有 12 种 RAT 试剂盒对检测奥密克戎 BA.2 的分析灵敏度相当。本研究中选择的 RAT 试剂盒可能用于快速传播的奥密克戎 BA.2 的一线筛查。

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