Infect Chemother.  2022 Jun;54(2):360-363. 10.3947/ic.2022.0047.

Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab

• Ham SY
• Jeong H
• Jung J
• Kim ES
• Park KU
• Kim HB
• Park JS
• Song KH

• KMID: 2531025
• DOI: http://doi.org/10.3947/ic.2022.0047

Abstract

The STANDARD™ M10 severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) assay (M10 assay) (SD Biosensor Inc., Suwon, Korea) is a rapid, fully-automated, cartridgetype molecular diagnostic assay that detects SARS-CoV-2 RNA using primers and probes for each target gene (ORF1ab gene, E gene). This study evaluated its performance by assessing its concordance with the approved SARS-CoV-2 real-time PCR assay. Tests were performed on 80 nasopharyngeal samples. The sensitivity and specificity of the M10 assay were 100%. The M10 assay effectively diagnosed SARS-CoV-2 infection, and it was comparable to the approved SARS-CoV-2 real-time PCR assay. It is a viable point-of-care test due to its short turnaround time.

Keyword

COVID-19; SARS-CoV-2 RT-PCR testing; COVID-19 nucleic acid testing