Yoshihiko Kiyasu, Masato Owaku, Yusaku Akashi, Yuto Takeuchi, ... Hiromichi Suzuki, Journal of Infection and Chemotherapy, 2021
国内で幅広く設置されている、POCT型遺伝子検査装置：スマートジーンの臨床性能試験
要点
1. 第4波（2021春）で累計1150検体（鼻咽頭791, 鼻腔359）を、スマートジーン用と基準検査用（感染研N1,N2)に2本検体をつくばPCRセンターで連続的採取し評価
2. 基準検査法と比較し高い一致率を示した。
1) 鼻咽頭
全体一致率：99.2% (95% confidence interval [CI]: 98.4–99.7%),
陽性一致率：94.1% (95% CI: 85.6–98.4%)
陰性一致率：99.7% (95% CI: 99.0–100%),
2) 鼻腔
全体一致率：98.9% (95% CI: 97.2–99.7%)
陽性一致率：98.0% (95% CI: 89.6–100%)
陰性一致率：99.0% (95% CI: 97.2–99.8%)
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.
