Clinical validation of the Siemens quantitative SARS-CoV-2 spike IgG assay (sCOVG) reveals improved sensitivity and a good correlation with virus neutralization titers

Clinical validation of the Siemens quantitative SARS-CoV-2 spike IgG assay (sCOVG) reveals improved sensitivity and a good correlation with virus neutralization titers
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DOI:
10.1515/cclm-2021-0214
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发表时间:
2021-01-01
影响因子:
6.8
通讯作者:
Hoermann, Gregor
Hoermann, Gregor
中科院分区:
医学2区
文献类型:
--
作者:
Irsara, Christian;Egger, Alexander E.;Hoermann, Gregor

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目的:严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染引起2019冠状病毒病(COVID-19)并诱导特异性抗体反应。检测针对刺突(5)蛋白的受体结合结构域(RBD)的IgG的血清学测定可用于监测感染或疫苗接种后的免疫应答。我们的研究的目的是评估西门子SARS-CoV-2 IgG(sCOVG)assay.Methods的临床性能:西门子sCOVG测试的灵敏度和特异性进行了评估178例SARS-CoV-2感染和160个大流行前的样本相比,其前身测试COV 2G。结果:sCOVG检测的特异性为99.4%,敏感性为90.5%(COV 2G检测为78.7%; pCOV 2G检测为78.7%。
Objectives: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections cause coronavirus disease 2019 (COVID-19) and induce a specific antibody response. Serological assays detecting IgG against the receptor binding domain (RBD) of the spike (5) protein are useful to monitor the immune response after infection or vaccination. The objective of our study was to evaluate the clinical performance of the Siemens SARS-CoV-2 IgG (sCOVG) assay.Methods: Sensitivity and specificity of the Siemens sCOVG test were evaluated on 178 patients with SARS-CoV-2-infection and 160 pre-pandemic samples in comparison with its predecessor test COV2G. Furthermore, correlation with virus neutralization titers was investigated on 134 samples of convalescent COVID-19 patients.Results: Specificity of the sCOVG test was 99.4% and sensitivity was 90.5% (COV2G assay 78.7%; p