Full Text of PDF (403k)
Article in Japanese
Abstract
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
Copyright © The Japanese Respiratory Society All Rights Reserved.