loading page

Clinical Performance of the STANDARD M10 SARS-CoV-2 Rapid RT-PCR Assay in an Emergency Department
  • +3
  • Mi Hyun Bae,
  • Dong-hyun Lee,
  • Eunhee Han,
  • Soorack Ryu,
  • Hyuk joong Choi,
  • Jieun Kim
Mi Hyun Bae
Hanyang University College of Medicine

Corresponding Author:[email protected]

Author Profile
Dong-hyun Lee
Gyeongsang National University Hospital
Author Profile
Eunhee Han
The Catholic University of Korea
Author Profile
Soorack Ryu
Hanyang University
Author Profile
Hyuk joong Choi
Hanyang University College of Medicine
Author Profile
Jieun Kim
Hanyang University College of Medicine
Author Profile


Background: In emergency departments, rapid screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is 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 an emergency department. Methods: From March to June 2022, two pairs of nasopharyngeal and oropharyngeal swabs were collected from patients visiting an emergency department. 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. Results: The study enrolled 1,971 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. Discordant results between STANDARD M10 and Allplex were observed only in specimens with Ct >33 using the Allplex. Conclusions: The STANDARD M10 showed reliable diagnostic performance for detecting SARS-CoV-2 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.
16 May 2023Submitted to Journal of Medical Virology
17 May 2023Submission Checks Completed
17 May 2023Assigned to Editor
17 May 2023Review(s) Completed, Editorial Evaluation Pending
18 May 2023Reviewer(s) Assigned
20 Jun 2023Editorial Decision: Revise Major
09 Nov 20231st Revision Received
10 Nov 2023Submission Checks Completed
10 Nov 2023Assigned to Editor
10 Nov 2023Review(s) Completed, Editorial Evaluation Pending
10 Nov 2023Reviewer(s) Assigned