Clinical performance of a rapid RT-PCR assay using STANDARD™ M10 SARS-CoV-2 between July 2022 and January 2023 in Korea

IF 2.1 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2024-09-02 DOI:10.1016/j.diagmicrobio.2024.116523

Eunhee Han , Jinyeong Kim , Young Jin Kim , Hyuk joong Choi , Mi Hyun Bae

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Abstract

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.

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使用 STANDARD™ M10 SARS-CoV-2 的快速 RT-PCR 检测法在 2022 年 7 月至 2023 年 1 月期间在韩国的临床表现

在 COVID-19 大流行期间，快速检测 SARS-CoV-2 对急诊科的临床管理至关重要。我们在 2022 年 7 月至 2023 年 1 月急诊科就诊患者中评估了最近开发的盒式快速 RT-PCR 检测法（STANDARD M10 SARS-CoV-2）的临床性能，当时 Omicron BA.5 亚系在韩国占主导地位。共有 534 份标本接受了 STANDARD M10 和标准 RT-PCR（Allplex SARS-CoV-2）检测。这两种检测方法的总体一致率、阳性一致率和阴性一致率分别为 99.6%、100% 和 99.6%。结果表明，与已有的 RT-PCR 检测方法相比，STANDARD M10 SARS-CoV-2 检测方法是研究期间检测 SARS-CoV-2 的可靠而有用的工具。新的快速 RT-PCR 将扩大快速诊断的多样性，有助于解决全球诊断资源供应不平衡的问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.