한은희 (가톨릭대학교 의과대학)

한빛사논문

조회289

한은희Eunhee Han

가톨릭대학교 의과대학

J. Med. Virol., Dec 2023, 95 (12) | https://doi.org/10.1002/jmv.29330 Clinical performance of the STANDARD M10 SARS-CoV-2 rapid RT-PCR assay in patients visiting an emergency department

Dong-Hyun Lee ¹, Eunhee Han ², Soorack Ryu ³, Hyuk Joong Choi ⁴, Jieun Kim ⁵, Jinyeong Kim⁶, Mi Hyun Bae ⁷

¹Department of Laboratory Medicine, Gyeongsang National University Hospital, Jinju, South Korea.

²Department of Laboratory Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.

³Biostatistical Consulting and Research Laboratory, Medical Research Collaborating Center, Hanyang University, Seoul, South Korea.

⁴Department of Emergency Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.

⁵Department of Internal Medicine, Division of Infectious Disease, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.

⁶Department of Internal Medicine, Division of Infectious Disease, Hanyang University Guri Hospital, Guri, South Korea.

⁷Department of Laboratory Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea.

Correspondence Mi Hyun Bae

Abstract

In emergency departments, rapid screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was important for arranging limited isolation resources and patient care during the coronavirus disease 2019 (COVID-19) pandemic. STANDARD M10 SARS-CoV-2 (SD Biosensor) is a recently developed cartridge-based RT-PCR that provides a turnaround time of 1 h, which is shorter than that for conventional RT-PCR. This study evaluated the clinical performance of STANDARD M10 in patients visiting an emergency department. From March to June 2022, two specimens were collected from patients visiting an emergency department. Each specimen comprised one nasopharyngeal and one oropharyngeal swab. Respective specimens underwent rapid RT-PCR using STANDARD M10 and conventional RT-PCR using Allplex SARS-CoV-2 (Seegene). When discordant results occurred, specimens undergoing the STANDARD M10 were retested with the Allplex to exclude specimen variations. Retest results replaced initial results of the Allplex. Clinical performance of STANDARD M10 was compared with Allplex. The study enrolled 1971 patients. COVID-19 prevalence was 6.2% based on the Allplex. Compared with the Allplex, overall agreement, positive percent agreement, and negative percent agreement of STANDARD M10 were 99.5% (95% CI: 99.1%-99.8%), 95.9% (95% CI: 90.8%-98.3%), and 99.8% (95% CI: 99.4%-99.9%), respectively. Nine discordant results were all positive on droplet digital PCR, except for one specimen that was positive with STANDARD M10. The STANDARD M10 showed reliable diagnostic performance for detecting SARS-CoV-2 from patients visiting in emergency departments and is a useful tool in emergency healthcare systems because of its easy-to-use cartridge-based assay and short resulting time for detecting SARS-CoV-2.

논문정보

형식Research article
게재일2023년 12월 (BRIC 등록일 2023-12-21)
연구진국내 연구진
분야 의약학 > 감염의학

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