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.
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.
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DOI：
10.1016/j.jiac.2021.12.027
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发表时间：
2022-04
期刊：
影响因子：
--
通讯作者：
Suzuki H
中科院分区：
文献类型：
--
作者：
Kiyasu Y;Owaku M;Akashi Y;Takeuchi Y;Narahara K;Mori S;Nagano T;Notake S;Ueda A;Nakamura K;Ishikawa H;Suzuki H
Smart Gene是一种即时（POC）型自动化分子检测平台，可在1分钟的动手时间内完成。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。尚未评价Smart Gene SARS-CoV-2的分析和临床性能。从2021年3月25日至7月5日转诊至当地PCR中心的受试者中前瞻性采集鼻咽和前鼻样本。同时获得两个拭子用于Smart Gene SARS-CoV-2检测和参考实时RT-PCR检测，并将Smart Gene SARS-CoV-2的结果与参考实时RT-PCR检测进行比较。在总共1150份样本中，791份鼻咽样本中的68份和359份前鼻样本中的51份在参考实时RT-PCR检测中呈SARS-CoV-2阳性。在检测鼻咽样本中，Smart Gene SARS-CoV-2的总一致性、阳性一致性和阴性一致性分别为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显示总一致性、阳性一致性和阴性一致性分别为98.9%（95%CI：97.2-99.7%）、98.0%（95%CI：89.6-100%）和99.0%（95%CI：97.2-99.8%）。总共有5份样本在参考实时RT-PCR检测中呈阳性，在Smart Gene SARS-CoV-2检测中呈阴性，而5份样本在参考实时RT-PCR检测中呈阴性，在Smart Gene SARS-CoV-2检测中呈阳性。Smart Gene SARS-CoV-2在检测鼻咽和前鼻样本中的SARS-CoV-2方面表现出足够的分析性能。
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. 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. 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. Smart Gene SARS-CoV-2 showed sufficient analytical performance for the detection of SARS-CoV-2 in nasopharyngeal and anterior nasal samples.
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影响因子：
4.6
作者：
Takeuchi Y;Akashi Y;Kato D;Kuwahara M;Muramatsu S;Ueda A;Notake S;Nakamura K;Ishikawa H;Suzuki H
通讯作者：
Suzuki H
影响因子：
9.4
作者：
Kakiuchi, Toshihiko;Miyata, Ippei;Matsuo, Muneaki
通讯作者：
Matsuo, Muneaki
DOI：
10.1016/j.jiac.2021.07.005
发表时间：
2021-10
期刊：
Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy
影响因子：
--
作者：
Kiyasu Y;Takeuchi Y;Akashi Y;Kato D;Kuwahara M;Muramatsu S;Notake S;Ueda A;Nakamura K;Ishikawa H;Suzuki H
通讯作者：
Suzuki H
DOI：
10.1016/j.jiac.2021.07.006
发表时间：
2021-10
期刊：
Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy
影响因子：
--
作者：
Kurihara Y;Kiyasu Y;Akashi Y;Takeuchi Y;Narahara K;Mori S;Takeshige T;Notake S;Ueda A;Nakamura K;Ishikawa H;Suzuki H
通讯作者：
Suzuki H
DOI：
10.3390/diagnostics11061091
发表时间：
2021-06-15
期刊：
Diagnostics (Basel, Switzerland)
影响因子：
--
作者：
Rabaan AA;Tirupathi R;Sule AA;Aldali J;Mutair AA;Alhumaid S;Muzaheed;Gupta N;Koritala T;Adhikari R;Bilal M;Dhawan M;Tiwari R;Mitra S;Emran TB;Dhama K
通讯作者：
Dhama K