Analytical performance of four rapid molecular testing for SARS-CoV-2

IF 1.1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY

Journal of Laboratory Medicine Pub Date : 2022-11-17 DOI:10.1515/labmed-2022-0073

Y. Katayama, Ryosei Murai, Yuki Sato, M. Moriai, Shinya Nirasawa, Masachika Saeki, Yuki Yakuwa, Y. Fujiya, K. Kuronuma, Satoshi Takahashi

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引用次数: 0

Abstract

Abstract Objectives Various reagents and equipment for testing SARS-CoV-2 infections have been developed, particularly rapid molecular tests based on polymerase chain reaction (PCR). Methods We evaluated the analytical performance of four rapid molecular tests for SARS-CoV-2. We used 56 nasopharyngeal swabs from patients with confirmed SARS-CoV-2 infection; 36 diagnosed as positive by the Ampdirect™ 2019-nCoV Detection Kit (Shimadzu assay) were considered as true-positive samples. Results The sensitivity of Cobas® Liat SARS-CoV-2 and Flu A/B (Cobas) was the highest among the four molecular test kits. The limit of detection was 1.49 × 10−2 copies/µL (95% confidence interval [CI]: 1.46×10−2−1.51 × 10−2 copies/µL) for Cobas; 1.43 × 10−1 copies/µL (95% CI: 8.01×10−3−2.78 × 10−1 copies/µL) for Xpert® Xpress SARS-CoV-2 test (Xpert); 2.00 × 10−1 copies/µL (95% CI: 1.95×10−1-2.05 × 10−1 copies/µL) for FilmArray Respiratory Panel v2.1 (FilmArray); and 3.33 × 10 copies/µL (95% CI: 1.93 × 10–4.72×10 copies/µL) for Smart Gene® SARS-CoV-2 (Smart gene). Cobas also had a high sensitivity (100%) compared with Shimadzu assay. The sensitivities of Xpert, FilmArray, and Smart Gene were 97.2%, 97.2%, and 75.0%, respectively. The specificity of all tests was 100%. Conclusions In conclusion, the four rapid SARS-CoV-2 molecular test kits have high specificity and sensitivity for detecting SARS-CoV-2. As they are easy to use, they could be a useful method for detecting SARS-CoV-2.

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SARS-CoV-2四种快速分子检测的分析性能

摘要目的开发了多种检测SARS-CoV-2感染的试剂和设备，特别是基于聚合酶链反应(PCR)的快速分子检测。方法对4种SARS-CoV-2快速分子检测方法的分析性能进行评价。我们使用了来自确诊SARS-CoV-2感染患者的56份鼻咽拭子;经Ampdirect™2019-nCoV检测试剂盒(Shimadzu assay)诊断为阳性的36例为真阳性样本。结果Cobas®Liat对SARS-CoV-2和流感A/B (Cobas)的敏感性最高。Cobas的检出限为1.49 ×10−2 copies/µL(95%置信区间[CI]: 1.46×10−2−1.51 ×10−2 copies/µL);Xpert®Xpress SARS-CoV-2检测(Xpert) 1.43 ×10−1 copies/µL (95% CI: 8.01×10−3−2.78 ×10−1 copies/µL);2.00 ×10−1 copies/µL (95% CI: 1.95×10−1-2.05 ×10−1 copies/µL)， FilmArray Respiratory Panel v2.1;Smart Gene®SARS-CoV-2 (Smart基因)为3.33 ×10 copies/µL (95% CI: 1.93 × 10-4.72×10 copies/µL)。与岛津试验相比，Cobas也具有很高的灵敏度(100%)。Xpert、FilmArray和Smart Gene的敏感性分别为97.2%、97.2%和75.0%。所有检查的特异性均为100%。结论4种SARS-CoV-2快速分子检测试剂盒检测SARS-CoV-2具有较高的特异性和敏感性。由于它们易于使用，它们可能是检测SARS-CoV-2的有用方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Laboratory Medicine Mathematics-Discrete Mathematics and Combinatorics

CiteScore

2.50

自引率

0.00%

发文量

审稿时长

10 weeks

期刊介绍： The Journal of Laboratory Medicine (JLM) is a bi-monthly published journal that reports on the latest developments in laboratory medicine. Particular focus is placed on the diagnostic aspects of the clinical laboratory, although technical, regulatory, and educational topics are equally covered. The Journal specializes in the publication of high-standard, competent and timely review articles on clinical, methodological and pathogenic aspects of modern laboratory diagnostics. These reviews are critically reviewed by expert reviewers and JLM’s Associate Editors who are specialists in the various subdisciplines of laboratory medicine. In addition, JLM publishes original research articles, case reports, point/counterpoint articles and letters to the editor, all of which are peer reviewed by at least two experts in the field.