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用于从鼻咽拭子中基于逆转录聚合酶链反应(RT-PCR)检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的雅培实时SARS-CoV-2检测法与力康新型冠状病毒实时多重检测试剂盒的比较

COMPARISON OF ABBOTT REAL TIME SARS-COV-2 ASSAY AND LIFERIVER NOVEL CORONAVIRUS REAL TIME MULTIPLEX KIT FOR THE RT-PCR BASED DETECTION OF SARS-COV-2 FROM NASOPHARYNGEAL SWABS.

作者信息

Stojčević-Maletić Jelena, Barjaktarović Iva, Đerić Mirjana, Čabarkapa Velibor, Petrović Vladimir, Patić Aleksandra, Bogdanović-Vasić Slobodanka

机构信息

University of Novi Sad, Faculty of Medicine, Novi Sad, Serbia.

University Clinical Center of Vojvodina, Center for Laboratory Diagnostics, Novi Sad, Serbia.

出版信息

Acta Clin Croat. 2024 Oct;63(2):275-282. doi: 10.20471/acc.2024.63.02.3.

Abstract

The objective of this study was to compare performance of two authorized tests, the Abbott Real Time SARS-CoV-2 (ACOV) assay (Abbott Molecular Inc., North Chicago, IL, USA) and Liferiver Novel Coronavirus Real Time Multiplex RT-PCR (Liferiver 2019-nCoV) kit (BioVendor Group, Brno, Czech Republic), and to determine whether the selection of targeted genes has an impact on test specificity. We included 105 nasopharyngeal swabs from adult individuals with symptoms or suspected of coronavirus disease 2019 (COVID-19), aged from 26 to 91 years, previously tested by the ACOV and subsequently tested by the Liferiver 2019-nCoV. In this comparative analysis, we found that the ACOV assay detected more cases of COVID-19 infection than the Liferiver 2019-nCoV assay. The Liferiver 2019-nCoV kit showed a high level of agreement with the ACOV assay. The positive percent agreement was 88.89% (95% confidence intervals (95% CI): 77.42%-100.0%), and the kappa coefficient (kappa) was 0.901 (95% CI: 0.817-0.985). The negative percent agreement was 94.12% (95% CI: 89.74%-98.50%), while 4.76% of SARS-CoV-2 cases were false-negative using the Liferiver test. However, due to the possible false-negative results using the Liferiver 2019-nCOV test, we recommend complete testing with the ACOV assay.

摘要

本研究的目的是比较两种经授权的检测方法,即雅培实时SARS-CoV-2(ACOV)检测法(美国伊利诺伊州北芝加哥市雅培分子公司)和利菲河新型冠状病毒实时多重逆转录聚合酶链反应(Liferiver 2019-nCoV)试剂盒(捷克共和国布尔诺市BioVendor集团)的性能,并确定靶向基因的选择是否对检测特异性有影响。我们纳入了105份来自26至91岁有症状或疑似感染2019冠状病毒病(COVID-19)的成年个体的鼻咽拭子,这些样本先前已通过ACOV检测,随后又通过Liferiver 2019-nCoV检测。在这项比较分析中,我们发现ACOV检测法检测出的COVID-19感染病例比Liferiver 2019-nCoV检测法更多。Liferiver 2019-nCoV试剂盒与ACOV检测法显示出高度一致性。阳性百分一致性为88.89%(95%置信区间(95%CI):77.42%-100.0%),kappa系数(kappa)为0.901(95%CI:0.817-0.985)。阴性百分一致性为94.12%(95%CI:89.74%-98.50%),而使用Liferiver检测法时,4.76%的SARS-CoV-2病例为假阴性。然而,由于使用Liferiver 2019-nCOV检测法可能出现假阴性结果,我们建议使用ACOV检测法进行全面检测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9729/11912847/f2f5a4b5da17/acc-63-275-f1.jpg

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