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. 2023 Jan;29(1):115-117.
doi: 10.1016/j.jiac.2022.09.019. Epub 2022 Sep 30.

Diagnostic test property of transcription-reverse transcription concerted reaction reagent TRCReady® SARS-CoV-2 i using nasopharyngeal swab samples

Megumi Ogawa  1 , Manami Sato  1 , Asuka Yamakami  1 , Yuki Hayasaka  1 , Yoshiko Saya  1 , Kurando Une  2 , Satoshi Iwai  2 , Shigeo Tsuchiya  2 , Yumiko Mikami  1 , Chizumi Fukazawa  1 , Yuki Uehara  3
Affiliations

Diagnostic test property of transcription-reverse transcription concerted reaction reagent TRCReady® SARS-CoV-2 i using nasopharyngeal swab samples

Megumi Ogawa et al. J Infect Chemother. 2023 Jan.

Abstract

TRCReady® SARS-CoV-2 i is a reagent for transcription-reverse transcription concerted reaction (TRC) to detect SARS-CoV-2 N2 gene, used with the automated rapid isothermal nucleic acid amplification test (NAAT) analyzer TRCReady®-80. Sensitivity and specificity of TRCReady® SARS-CoV-2 i was assessed by comparison with the results of real-time reverse transcription-polymerase chain reaction (RT-PCR) using nasopharyngeal swab samples. From November 2020 to March 2021, a total of 441 nasopharyngeal swabs were obtained and analyzed both with TRCReady® SARS-CoV-2 i and RT-PCR. Sensitivity and specificity of TRCReady® SARS-CoV-2 i were 94.6% (53/56) and 99.2% (382/385), respectively. Reaction time to positivity of TRCReady® SARS-CoV-2 i ranged from 1.166 to 9.805 (median: 2.887) min, and minimum detection sensitivity of TRCReady® SARS-CoV-2 i was 9 copies per test, with reaction time as 5.014 min. Detection of SARS-CoV-2 gene from nasopharyngeal swab sample using TRCReady® SARS-CoV-2 i shows comparative diagnostic test accuracy with RT-PCR, and can be used as a useful test to diagnose SARS-CoV-2 infection.

Keywords: Nasopharyngeal swab; Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); Rapid nucleic acid amplification test; TRCReady® SARS-CoV-2 i; Transcription-reverse transcription concerted reaction.

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Conflict of interest statement

Declaration of competing interest KU, SI and ST are the employees of Tosoh Corporation. The reagent TRCReady® SARS-CoV-2 i and part of publication fee of this study was provided by Tosoh Corporation.

Figures

Fig. 1
Fig. 1
Correlation of the time to positivity of TRCReady® SARS-CoV-2 i and RT-PCR. RT-PCR, real-time reverse transcription-polymerase chain reaction.
See this image and copyright information in PMC

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