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Abstract

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Article in Japanese

Original Article

Clinical performance evaluation of "Smart Gene® SARS-CoV-2 Detection Reagent"

Kentaro Wakamatsua  Kouta Katsukib  Tetsuharu Ikedab  Tsuyoshi Uenoa  Ruriko Kiyotania  Izumi Fukuia  Sanae Makia  Zenzo Nagasawac  Nobuhiko Nagatad  Masayuki Kawasakia 

aDepartment of Respiratory Medicine, National Hospital Organization Omuta National Hospital
bDepartment of Clinical Laboratory, National Hospital Organization Omuta National Hospital
cDepartment of Medical Technology and Science, Faculty of Fukuoka Health Care, International University of Health and Welfare
dDepartment of Respiratory Medicine, Fukuoka Sanno Hospital

ABSTRACT

The newly developed "Smart Gene® SARS-CoV-2 Detection Reagent" (Mizuho Medy Co., Ltd.) was evaluated among a total of 128 patients (147 samples) who were either confirmed COVID-19 patients or suspected COVID-19 patients. The evaluation results were as follows: sensitivity 98.3% (59/60) and specificity 98.9% (86/87) compared with the reverse transcription polymerase chain reaction (RT-PCR) method of the National Institute of Infectious Diseases. In addition, the detection sensitivity was considered to be positive up to about 10 copies/test from the copy number distribution of SARS-CoV-2 RNA. This reagent enables RT-PCR testing of COVID-19 with a simple measurement operation and is expected to be widely used in various medical institutions.

KEYWORDS

Coronavirus disease 2019 (COVID-19)  Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)  Polymerase chain reaction 

Received 20 Nov 2020 / Accepted 2 Mar 2021

AJRS, 10(3): 229-235, 2021

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