临床评估快速核酸扩增即时检测（Smart Gene SARS-CoV-2）在分析鼻咽和前鼻样本中的应用。
Clinical evaluation of the rapid nucleic acid amplification point-of-care test (Smart Gene SARS-CoV-2) in the analysis of nasopharyngeal and anterior nasal samples.
机构信息
Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo Tsukuba, Ibaraki, 305-8558, Japan; Department of Infectious Diseases, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan.
Mizuho Medy Co., Ltd., 5-4 Fujinoki-machi, Tosu City, Saga, 841-0048, Japan.
出版信息
J Infect Chemother. 2022 Apr;28(4):543-547. doi: 10.1016/j.jiac.2021.12.027. Epub 2021 Dec 31.
INTRODUCTION
Smart Gene is a point-of-care (POC)-type automated molecular testing platform that can be performed with 1 min of hands-on-time. Smart Gene SARS-CoV-2 is a newly developed Smart Gene molecular assay for the detection of SARS-CoV-2. The analytical and clinical performance of Smart Gene SARS-CoV-2 has not been evaluated.
METHODS
Nasopharyngeal and anterior nasal samples were prospectively collected from subjects referred to the local PCR center from March 25 to July 5, 2021. Two swabs were simultaneously obtained for the Smart Gene SARS-CoV-2 assay and the reference real-time RT-PCR assay, and the results of Smart Gene SARS-CoV-2 were compared to the reference real-time RT-PCR assay.
RESULTS
Among a total of 1150 samples, 68 of 791 nasopharyngeal samples and 51 of 359 anterior nasal samples were positive for SARS-CoV-2 in the reference real-time RT-PCR assay. In the testing of nasopharyngeal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 99.2% (95% confidence interval [CI]: 98.4-99.7%), 94.1% (95% CI: 85.6-98.4%) and 99.7% (95% CI: 99.0-100%), respectively. For anterior nasal samples, Smart Gene SARS-CoV-2 showed the total, positive and negative concordance of 98.9% (95% CI: 97.2-99.7%), 98.0% (95% CI: 89.6-100%) and 99.0% (95% CI: 97.2-99.8%), respectively. In total, 5 samples were positive in the reference real-time RT-PCR assay and negative in the Smart Gene SARS-CoV-2 assay, whereas 5 samples were negative in the reference real-time RT-PCR assay and positive in the Smart Gene SARS-CoV-2 assay.
CONCLUSION
Smart Gene SARS-CoV-2 showed sufficient analytical performance for the detection of SARS-CoV-2 in nasopharyngeal and anterior nasal samples.
简介
Smart Gene 是一种即时检测（POC）型自动化分子检测平台，操作时间仅需 1 分钟。Smart Gene SARS-CoV-2 是一种新开发的用于检测 SARS-CoV-2 的 Smart Gene 分子检测方法。尚未评估 Smart Gene SARS-CoV-2 的分析和临床性能。
方法
2021 年 3 月 25 日至 7 月 5 日，前瞻性地从当地 PCR 中心送检的患者中采集鼻咽和前鼻样本。同时对两种拭子进行 Smart Gene SARS-CoV-2 检测和参考实时 RT-PCR 检测，并将 Smart Gene SARS-CoV-2 的检测结果与参考实时 RT-PCR 检测结果进行比较。
结果
在总共 1150 个样本中，791 个鼻咽样本中有 68 个和 359 个前鼻样本中有 51 个在参考实时 RT-PCR 检测中对 SARS-CoV-2 呈阳性。在鼻咽样本的检测中，Smart Gene SARS-CoV-2 的总、阳性和阴性符合率分别为 99.2%（95%置信区间[CI]：98.4-99.7%）、94.1%（95%CI：85.6-98.4%）和 99.7%（95%CI：99.0-100%）。对于前鼻样本，Smart Gene SARS-CoV-2 的总、阳性和阴性符合率分别为 98.9%（95%CI：97.2-99.7%）、98.0%（95%CI：89.6-100%）和 99.0%（95%CI：97.2-99.8%）。总的来说，5 个样本在参考实时 RT-PCR 检测中呈阳性而在 Smart Gene SARS-CoV-2 检测中呈阴性，而 5 个样本在参考实时 RT-PCR 检测中呈阴性而在 Smart Gene SARS-CoV-2 检测中呈阳性。
结论
Smart Gene SARS-CoV-2 在鼻咽和前鼻样本中检测 SARS-CoV-2 时具有足够的分析性能。
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