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KMID : 1144320220540020360
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감염과 화학요법
2022 Volume.54 No. 2 p.360 ~ p.363
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Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab
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Ham Sin-Young
Jeong Hyeon-Ju
Jung Jong-Tak
Kim Eu-Suk
Park Kyoung-Un
Kim Hong-Bin
Park Jeong-Su
Song Kyoung-Ho
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Abstract
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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, cartridge-type 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.
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KEYWORD
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COVID-19, SARS-CoV-2 RT-PCR testing, COVID-19 nucleic acid testing
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