Introduction
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which
causes coronavirus disease 2019 (COVID-19), has rapidly spread
worldwide, and accurate diagnosis of SARS-CoV-2 infection is crucial for
reducing its transmission and optimizing timely patient management. The
standard method for detecting SARS-CoV-2 is real-time
reverse-transcription polymerase chain reaction (RT-PCR) assay with
nasopharyngeal and oropharyngeal swabs.1 The RT-PCR
assay ensures high sensitivity and specificity but generally requires
specialized laboratory personnel and long turnaround times. Allplex
SARS-CoV-2 (Seegene, Seoul, Korea; Allplex) is one of the most commonly
used conventional RT-PCR assay in Korea and
worldwide.2,3 While it provides reliable results, it
takes approximately 4 h to report results including more than 1 h of
hands-on time.4 Rapid detection of SARS-CoV-2 is a key
component to the appropriate and timely allocation of limited national
or institutional isolation supplies; furthermore, rapid detection
results directs the next step in providing appropriate medical care for
patients and preventing spread of the virus in emergency departments;
conventional RT-PCR assay is inadequate in meeting the urgent medical
process of emergency departments.
Rapid RT-PCR systems for SARS-CoV-2, such as the Xpert Xpress SARS-CoV-2
assay (Cepheid, CA, USA), have received Emergency Use Authorization from
the U.S. and Korea in the early phase of the COVID-19
pandemic.5 The rapid RT-PCR platform provides accurate
results within 1 h; hence, the method was useful, especially in
emergency departments. However, the method could not be used
appropriately in Korea because the supply of reagents was insufficient,
and the Korean health insurance system strictly limited test indication.
Hence, the STANDARD M10 SARS-CoV-2 assay (SD Biosensor, Suwon, Korea;
STANDARD M10), which can rapidly detect SARS-CoV-2 based on a
point-of-care RT-PCR assay targeting the envelope (E ) and open
reading frame 1ab gene (ORF1ab ) was introduced in the early phase
of the Omicron surge in Korea.6 However, because only
a few reports have validated the clinical performance of STANDARD M10 in
a clinical setting, this study aimed to conduct an on-field evaluation
with a large cohort of patients to estimate the clinical performance of
STANDARD M10 in an emergency department compared with that of a standard
RT-PCR method using Allplex.