Clinical Performance of the STANDARD M10 SARS-CoV-2 Rapid RT-PCR Assay
in an Emergency Department
Abstract
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.