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Cobas® Liat®系统与赛沛®GeneXpert®系统在鼻咽拭子和口咽后部唾液中检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的性能比较

Performance comparison of the Cobas® Liat® and Cepheid® GeneXpert® systems on SARS-CoV-2 detection in nasopharyngeal swab and posterior oropharyngeal saliva.

作者信息

Tsang Hin Fung, Leung Wai Ming Stanley, Chan Lawrence Wing Chi, Cho William Chi Shing, Wong Sze Chuen Cesar

机构信息

Department of Clinical Laboratory and Pathology, Hong Kong Adventist Hospital, Hong Kong Special Administrative Region.

Department of Health Technology and Informatics, Hong Kong Polytechnic University, Hong Kong Special Administrative Region.

出版信息

Expert Rev Mol Diagn. 2021 May;21(5):515-518. doi: 10.1080/14737159.2021.1919513. Epub 2021 Apr 28.

DOI:10.1080/14737159.2021.1919513
PMID:33906571
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8095157/
Abstract

: Nucleic acid amplification tests (NAATs) based methods such as real-time reverse transcription polymerase-chain reaction (real-time RT-PCR) are the gold standard for diagnosis of current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The cobas® Liat® and cepheid® GeneXpert® systems are two rapid real-time RT-PCR platforms offering rapid, specimen-to-answer detection of SARS-CoV-2.: In this study, we compared the performance of these two systems on SARS-CoV-2 detection in 9 nasopharyngeal swab (NPS) and 70 posterior oropharyngeal saliva specimens collected from 79 patients suspected of SARS-CoV-2 infection between August 2020 and March 2021.: The Positive Percent Agreement (PPA), Negative Percent Agreement (NPA) and overall Percent Agreement (OPA) between cepheid® Xpress SARS-CoV-2 assay and cobas® Liat® SARS-CoV-2 & Influenza A/B assay were found to be 100%. We demonstrated an excellent overall test concordance of the Liat® SARS-CoV-2 & Influenza A/B assay and Xpress SARS-CoV-2 assay. The small sample size of SARS-CoV-2 positive and weak-positive specimens is the inherent limitation of this study.: The performance of the cobas® Liat® SARS-CoV-2 & Influenza A/B assay is equivalent to the cepheid® Xpress SARS-CoV-2 assay for SARS-CoV-2 detection using NPS and posterior oropharyngeal saliva.

摘要

基于核酸扩增检测(NAATs)的方法,如实时逆转录聚合酶链反应(实时RT-PCR),是诊断严重急性呼吸综合征冠状病毒2(SARS-CoV-2)当前感染的金标准。cobas® Liat®和赛沛® GeneXpert®系统是两个快速实时RT-PCR平台,可对SARS-CoV-2进行快速的样本到结果检测。

在本研究中,我们比较了这两种系统对2020年8月至2021年3月期间从79名疑似SARS-CoV-2感染患者采集的9份鼻咽拭子(NPS)和70份口咽后部唾液标本中SARS-CoV-2的检测性能。

发现赛沛® Xpress SARS-CoV-2检测与cobas® Liat® SARS-CoV-2 & 甲型/乙型流感检测之间的阳性百分一致性(PPA)、阴性百分一致性(NPA)和总体百分一致性(OPA)均为100%。我们证明了Liat® SARS-CoV-2 & 甲型/乙型流感检测和Xpress SARS-CoV-2检测具有出色的总体检测一致性。SARS-CoV-2阳性和弱阳性标本的样本量小是本研究的固有局限性。

对于使用NPS和口咽后部唾液进行SARS-CoV-2检测,cobas® Liat® SARS-CoV-2 & 甲型/乙型流感检测的性能与赛沛® Xpress SARS-CoV-2检测相当。