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2
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3
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一种自动化逆转录-隔热等温 PCR 检测严重急性呼吸综合征冠状病毒 2 的临床验证。

Clinical validation of an automated reverse transcription-insulated isothermal PCR assay for the detection of severe acute respiratory syndrome coronavirus 2.

机构信息

Department of Laboratory Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.

Department of Laboratory Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.

出版信息

J Microbiol Immunol Infect. 2021 Jun;54(3):522-526. doi: 10.1016/j.jmii.2021.01.005. Epub 2021 Feb 1.

DOI:10.1016/j.jmii.2021.01.005
PMID:33582073
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7849545/
Abstract

To determine clinical performance of the single-target SARS-CoV-2 orf 1 ab reverse transcription-insulated isothermal PCR (RT-iiPCR) assay, the positive percentage agreement between this assay and a laboratory real-time RT-PCR assay was 96.8% (30 of 31; 95% confidence interval [CI], 90.5%-100%) and the negative percentage agreement was 97.1% (67 of 69; 95% CI, 93.1%-100%).

摘要

为了确定单靶标 SARS-CoV-2 ORF1ab 逆转录恒温 PCR（RT-iiPCR）检测的临床性能，该检测与实验室实时 RT-PCR 检测的阳性符合率为 96.8%（30/31；95%置信区间 [CI]，90.5%-100%），阴性符合率为 97.1%（67/69；95%CI，93.1%-100%）。