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三种全自动血清学检测方法在有症状和无症状的新冠病毒感染者中的诊断效率及其与新型替代病毒中和试验的相关性

Diagnostic Efficiency of Three Fully Automated Serology Assays and Their Correlation with a Novel Surrogate Virus Neutralization Test in Symptomatic and Asymptomatic SARS-COV-2 Individuals.

作者信息

Younes Salma, Al-Jighefee Hadeel, Shurrab Farah, Al-Sadeq Duaa W, Younes Nadin, Dargham Soha R, Al-Dewik Nader, Qotba Hamda, Syed Mohamed, Alnuaimi Ahmed, Yassine Hadi M, Tang Patrick, Abu-Raddad Laith J, Nasrallah Gheyath K

机构信息

Biomedical Research Center, Qatar University, Doha P.O. Box 2713, Qatar.

Department of Biomedical Science, College of Health Sciences, Member of QU Health, Qatar University, Doha P.O. Box 2713, Qatar.

出版信息

Microorganisms. 2021 Jan 25;9(2):245. doi: 10.3390/microorganisms9020245.

Abstract

To support the deployment of serology assays for population screening during the COVID-19 pandemic, we compared the performance of three fully automated SARS-CoV-2 IgG assays: Mindray CL-900i (target: spike [S] and nucleocapsid [N]), BioMérieux VIDAS3 (target: receptor-binding domain [RBD]) and Diasorin LIAISONXL (target: S1 and S2 subunits). A total of 111 SARS-CoV-2 RT-PCR- positive samples collected at ≥ 21 days post symptom onset, and 127 pre-pandemic control samples were included. Diagnostic performance was assessed in correlation to RT-PCR and a surrogate virus-neutralizing test (sVNT). Moreover, cross-reactivity with other viral antibodies was investigated. Compared to RT-PCR, LIAISONXL showed the highest overall specificity (100%), followed by VIDAS3 (98.4%) and CL-900i (95.3%). The highest sensitivity was demonstrated by CL-900i (90.1%), followed by VIDAS3 (88.3%) and LIAISONXL (85.6%). The sensitivity of all assays was higher in symptomatic patients (91.1-98.2%) compared to asymptomatic patients (78.4-80.4%). In correlation to sVNT, all assays showed excellent sensitivities (92.2-96.1%). In addition, VIDAS3 demonstrated the best correlation (r = 0.75) with the sVNT. The present study provides insights on the performance of three fully automated assays, which could help diagnostic laboratories in the choice of a particular assay according to the intended use.

摘要

为支持在新冠疫情期间开展人群血清学检测以进行筛查,我们比较了三种全自动严重急性呼吸综合征冠状病毒2(SARS-CoV-2)IgG检测方法的性能:迈瑞CL-900i(检测靶点:刺突蛋白[S]和核衣壳蛋白[N])、生物梅里埃VIDAS3(检测靶点:受体结合域[RBD])和索灵LIAISON XL(检测靶点:S1和S2亚基)。共纳入了111份症状出现后≥21天采集的SARS-CoV-2逆转录聚合酶链反应(RT-PCR)阳性样本,以及127份疫情前的对照样本。根据RT-PCR和替代病毒中和试验(sVNT)评估诊断性能。此外,还研究了与其他病毒抗体的交叉反应性。与RT-PCR相比,LIAISON XL显示出最高的总体特异性(100%),其次是VIDAS3(98.4%)和CL-900i(95.3%)。CL-900i显示出最高的灵敏度(90.1%),其次是VIDAS3(88.3%)和LIAISON XL(85.6%)。与无症状患者(78.4-80.4%)相比,所有检测方法在有症状患者中的灵敏度更高(91.1-98.2%)。与sVNT相关,所有检测方法均显示出优异的灵敏度(92.2-96.1%)。此外,VIDAS3与sVNT的相关性最佳(r = 0.75)。本研究提供了关于三种全自动检测方法性能的见解,这有助于诊断实验室根据预期用途选择特定的检测方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31d0/7912688/0e098a02662f/microorganisms-09-00245-g001.jpg

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