The Journal of the Japanese Society for Clinical Microbiology

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[Vol.31 No.2 contents]
Japanese / English

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Article in Japanese

ArticleTitle Validation of a new SARS-CoV-2 gene detection POCT reagent "Smart Gene COVID-19 detection kit" with nasopharyngeal swab
Language J
AuthorList Ataru Moriya1), Kei Yamamoto2), Toru Akiyama3), Noriko Kinoshita2), Tsutomu Sudo2), Ayano Motohashi1), Ayaka Usami1), Erina Isaka1), Honami Ando1), Hitoshi Ohki1), Masami Kurokawa1), Kazuhisa Mezaki1), Akihito Tanaka1), Michi Shoji1), Mitsuru Ozeki1), Moto Kimura4), Norio Ohmagari2)
Affiliation 1) Laboratory Testing Department, Center Hospital of the National Center for Global Health and Medicine
2) Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine
3) Research Institute, National Center for Global Health and Medicine
4) Center for Clinical Sciences, National Center for Global Health and Medicine
Publication J.J.C.M.: 31 (2), 103-107, 2021
Received September 26, 2020
Accepted November 11, 2020
Abstract COVID-19 is determined by detection of SARS-CoV-2 gene with reverse-transcription PCR (RT-PCR) in routine clinical practice. A new POCT RT-PCR test for detection of SARS-CoV-2 called Smart Gene kit (SG test) was launched by MIZUHO MEDY Co., Ltd in Japan in August 2020. The SG test is a method that enables gene detection with a simple one-step operation, and is a gene detection method based on the quenching probe method. The aim of this study was to verified basic analytical of SG test, used 25 samples of nasopharyngeal swabs cryopreserved with virus transport medium. The comparison method was measured by quantitative one-step RT-PCR (RT-qPCR). The comparison results were 100% sensitivity (10/10), 100% specificity (15/15), and 100% overall concordance (25/25). In this study, the minimum detection concentration of the SG test was 6.41 copies/5 μL. From this result, it was judged that the SG test has sufficient performance as a SARS-CoV-2 genetic test method. Because the SG test can be operated simple one step and easily, it will be possible to perform the genetic test of COVID-19 in a wide range of medical sites such as clinics and core hospitals. There is a shortage of PCR tests in Japan, but the SG test could be a key point to overcome this.
Keywords SARS-CoV-2, Smart Gene
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