2022 年 7 月至 2023 年 1 月期间，韩国使用 STANDARD™ M10 SARS-CoV-2 快速 RT-PCR 检测试剂盒的临床性能。
Clinical performance of a rapid RT-PCR assay using STANDARD™ M10 SARS-CoV-2 between July 2022 and January 2023 in Korea.
机构信息
Department of Laboratory Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Division of Infectious Disease, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, South Korea.
出版信息
Diagn Microbiol Infect Dis. 2024 Dec;110(4):116523. doi: 10.1016/j.diagmicrobio.2024.116523. Epub 2024 Sep 2.
Rapid detection of SARS-CoV-2 is essential for clinical management in the emergency department during the COVID-19 pandemic. We evaluated the clinical performance of the recently developed cartridge-based rapid RT-PCR assay (STANDARD M10 SARS-CoV-2) in patients visiting the emergency department from July 2022 to January 2023, which was when the Omicron BA.5 sublineage was predominant in Korea. A total of 534 specimens were subjected to the STANDARD M10 and standard RT-PCR (Allplex SARS-CoV-2) assays. The overall, positive, and negative percent agreements between these two assays were 99.6%, 100%, and 99.6%, respectively. The results showed that compared with the established RT-PCR assay, the STANDARD M10 SARS-CoV-2 assay is a reliable and useful tool for SARS-CoV-2 detection during the study period. The new rapid RT-PCR will expand the diversity in rapid diagnostics and can help resolve the global imbalance associated with the supply of diagnostic resources.
在 COVID-19 大流行期间，急诊科对 SARS-CoV-2 的快速检测对于临床管理至关重要。我们评估了最近开发的基于盒式的快速 RT-PCR 检测试剂盒（STANDARD M10 SARS-CoV-2）在 2022 年 7 月至 2023 年 1 月期间就诊于急诊科的患者中的临床性能，当时奥密克戎 BA.5 亚谱系在韩国占主导地位。共有 534 个标本接受了 STANDARD M10 和标准 RT-PCR（Allplex SARS-CoV-2）检测。这两种检测方法的总符合率、阳性符合率和阴性符合率分别为 99.6%、100%和 99.6%。结果表明，与已建立的 RT-PCR 检测方法相比，STANDARD M10 SARS-CoV-2 检测试剂盒在研究期间是一种可靠且有用的 SARS-CoV-2 检测工具。新的快速 RT-PCR 将扩大快速诊断的多样性，并有助于解决与诊断资源供应相关的全球不平衡问题。
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