Department of Clinical Laboratory, St. Luke's International Hospital, Tokyo, Japan.
Tosoh Corporation, Kanagawa, Japan.
J Infect Chemother. 2023 Jan;29(1):115-117. doi: 10.1016/j.jiac.2022.09.019. Epub 2022 Sep 30.
TRCReady® SARS-CoV-2 i is a reagent for transcription-reverse transcription concerted reaction (TRC) to detect SARS-CoV-2 N2 gene, used with the automated rapid isothermal nucleic acid amplification test (NAAT) analyzer TRCReady®-80. Sensitivity and specificity of TRCReady® SARS-CoV-2 i was assessed by comparison with the results of real-time reverse transcription-polymerase chain reaction (RT-PCR) using nasopharyngeal swab samples. From November 2020 to March 2021, a total of 441 nasopharyngeal swabs were obtained and analyzed both with TRCReady® SARS-CoV-2 i and RT-PCR. Sensitivity and specificity of TRCReady® SARS-CoV-2 i were 94.6% (53/56) and 99.2% (382/385), respectively. Reaction time to positivity of TRCReady® SARS-CoV-2 i ranged from 1.166 to 9.805 (median: 2.887) min, and minimum detection sensitivity of TRCReady® SARS-CoV-2 i was 9 copies per test, with reaction time as 5.014 min. Detection of SARS-CoV-2 gene from nasopharyngeal swab sample using TRCReady® SARS-CoV-2 i shows comparative diagnostic test accuracy with RT-PCR, and can be used as a useful test to diagnose SARS-CoV-2 infection.
TRCReady® SARS-CoV-2 i 是一种用于转录-逆转录协同反应 (TRC) 的试剂，用于检测 SARS-CoV-2 N2 基因，与自动化快速等温核酸扩增测试 (NAAT) 分析仪 TRCReady®-80 一起使用。通过与使用鼻咽拭子样本的实时逆转录聚合酶链反应 (RT-PCR) 结果进行比较，评估了 TRCReady® SARS-CoV-2 i 的敏感性和特异性。2020 年 11 月至 2021 年 3 月，共获得 441 份鼻咽拭子样本，分别用 TRCReady® SARS-CoV-2 i 和 RT-PCR 进行分析。TRCReady® SARS-CoV-2 i 的敏感性和特异性分别为 94.6%（53/56）和 99.2%（382/385）。TRCReady® SARS-CoV-2 i 的阳性反应时间范围为 1.166 至 9.805（中位数：2.887）分钟，TRCReady® SARS-CoV-2 i 的最小检测灵敏度为 9 拷贝/测试，反应时间为 5.014 分钟。使用 TRCReady® SARS-CoV-2 i 从鼻咽拭子样本中检测 SARS-CoV-2 基因与 RT-PCR 具有相当的诊断测试准确性，可作为诊断 SARS-CoV-2 感染的有用测试方法。
Drug Discov Ther. 2023-5-15
BMJ Open Gastroenterol. 2021-5
Cochrane Database Syst Rev. 2024-10-14
Zotero 插件