一种 SARS-CoV-2 S-RBD IgG 检测方法的分析和临床性能：与中和滴度的比较。
Analytical and clinical performances of a SARS-CoV-2 S-RBD IgG assay: comparison with neutralization titers.
机构信息
Department of Medicine-DIMED, Medical School, University of Padova, Padova, Italy.
Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy.
出版信息
Clin Chem Lab Med. 2021 Apr 14;59(8):1444-1452. doi: 10.1515/cclm-2021-0313. Print 2021 Jul 27.
OBJECTIVES
SARS-CoV-2 serology presents an important role in several aspects of COVID-19 pandemic. Immunoassays performances have to be accurately evaluated and correlated with neutralizing antibodies. We investigated the analytical and clinical performances of a SARS-CoV-2 RBD IgG assay, automated on a high throughput platform, and the correlation of the antibodies (Ab) levels with the plaque reduction neutralization (PRNT) Ab titers.
METHODS
A series of 546 samples were evaluated by SARS-CoV-2 RBD IgG assay (Snibe diagnostics), including 171 negative and 168 positive SARS-CoV-2 subjects and a further group of 207 subjects of the COVID-19 family clusters follow-up cohort.
RESULTS
Assay imprecision ranged from 3.98 to 12.18% being satisfactory at low and medium levels; linearity was excellent in all the measurement range. Considering specimens collected after 14 days post symptoms onset, overall sensitivity and specificity were 99.0 and 92.5%, respectively. A total of 281 leftover samples results of the PRNT test were available. An elevated correlation was obtained between the SARS-CoV-2 RBD IgG assay and the PRNT titer at univariate (=0.689) and multivariate (=0.712) analyses.
CONCLUSIONS
SARS-CoV-2 S-RBD IgG assay shows satisfactory analytical and clinical performances, and a strong correlation with sera neutralizing activity.
目的
SARS-CoV-2 血清学在 COVID-19 大流行的几个方面都具有重要作用。免疫测定的性能必须经过准确评估，并与中和抗体相关联。我们研究了一种 SARS-CoV-2 RBD IgG 测定的分析和临床性能，该测定在高通量平台上自动化进行，并将抗体（Ab）水平与蚀斑减少中和（PRNT）Ab 滴度相关联。
方法
对一系列 546 个样本进行了 SARS-CoV-2 RBD IgG 测定（Snibe diagnostics），包括 171 个阴性和 168 个 SARS-CoV-2 阳性样本，以及进一步的 207 个 COVID-19 家庭集群随访队列的样本。
结果
测定的不精密度范围为 3.98%至 12.18%，在低和中水平下令人满意；在所有测量范围内，线性度都很好。考虑到症状出现后 14 天采集的标本，总体敏感性和特异性分别为 99.0%和 92.5%。共有 281 个 PRNT 检测的剩余样本结果可用。在单变量（=0.689）和多变量（=0.712）分析中，SARS-CoV-2 RBD IgG 测定与 PRNT 滴度之间均获得了高度相关性。
结论
SARS-CoV-2 S-RBD IgG 测定具有令人满意的分析和临床性能，与血清中和活性具有很强的相关性。
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