用于从鼻咽拭子诊断COVID-19的STANDARD™ M10 SARS-CoV-2检测法的性能
Performance of STANDARD™ M10 SARS-CoV-2 Assay for the Diagnosis of COVID-19 from a Nasopharyngeal Swab.
作者信息
Ham Sin Young, Jeong Hyeonju, Jung Jongtak, Kim Eu Suk, Park Kyoung Un, Kim Hong Bin, Park Jeong Su, Song Kyoung-Ho
机构信息
Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
出版信息
Infect Chemother. 2022 Jun;54(2):360-363. doi: 10.3947/ic.2022.0047. Epub 2022 May 13.
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, 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.
摘要
STANDARD™ M10严重急性呼吸综合征冠状病毒2（SARS-CoV-2）检测法（M10检测法）（韩国水原SD生物传感器公司）是一种快速、全自动、 cartridge型分子诊断检测法，它使用针对每个靶基因（开放阅读框1ab基因、E基因）的引物和探针来检测SARS-CoV-2 RNA。本研究通过评估其与已批准的SARS-CoV-2实时PCR检测法的一致性来评价其性能。对80份鼻咽样本进行了检测。M10检测法的敏感性和特异性均为100%。M10检测法能有效诊断SARS-CoV-2感染，且与已批准的SARS-CoV-2实时PCR检测法相当。由于其周转时间短，它是一种可行的即时检测方法。
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