Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab
- Author:
Sin Young HAM
1
;
Hyeonju JEONG
;
Jongtak JUNG
;
Eu Suk KIM
;
Kyoung Un PARK
;
Hong Bin KIM
;
Jeong Su PARK
;
Kyoung-Ho SONG
Author Information
- Publication Type:Brief Communication
- From:Infection and Chemotherapy 2022;54(2):360-363
- CountryRepublic of Korea
- Language:English
- 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.
