Department of Biomedical Sciences and Human Oncology, University of Bari Aldo Moro Medical School, 70124 Bari, Italy.
Clinical Pathology Unit, University of Bari Aldo Moro, 70124 Bari, Italy.
Int J Mol Sci. 2022 Aug 24;23(17):9566. doi: 10.3390/ijms23179566.
Serological assays are useful in investigating the development of humoral immunity against SARS-CoV-2 in the context of epidemiological studies focusing on the spread of protective immunity. The plaque reduction neutralization test (PRNT) is the gold standard method to assess the titer of protective antibodies in serum samples. However, to provide a result, the PRNT requires several days, skilled operators, and biosafety level 3 laboratories. Therefore, alternative methods are being assessed to establish a relationship between their outcomes and PRNT results. In this work, four different immunoassays (Roche Elecsys® Anti SARS-CoV-2 S, Snibe MAGLUMI® SARS-CoV-2 S-RBD IgG, Snibe MAGLUMI® 2019-nCoV IgG, and EUROIMMUN® SARS-CoV-2 NeutraLISA assays, respectively) have been performed on individuals healed after SARS-CoV-2 infection. The correlation between each assay and the reference method has been explored through linear regression modeling, as well as through the calculation of Pearson’s and Spearman’s coefficients. Furthermore, the ability of serological tests to discriminate samples with high titers of neutralizing antibodies (>160) has been assessed by ROC curve analyses, Cohen’s Kappa coefficient, and positive predictive agreement. The EUROIMMUN® NeutraLISA assay displayed the best correlation with PRNT results (Pearson and Spearman coefficients equal to 0.660 and 0.784, respectively), as well as the ROC curve with the highest accuracy, sensitivity, and specificity (0.857, 0.889, and 0.829, respectively).
血清学检测在流行病学研究中用于调查针对 SARS-CoV-2 的体液免疫的发展情况，这些研究重点关注保护性免疫的传播。蚀斑减少中和试验（PRNT）是评估血清样本中保护性抗体滴度的金标准方法。然而，为了提供结果，PRNT 需要数天、熟练的操作人员和生物安全 3 级实验室。因此，正在评估替代方法，以建立它们的结果与 PRNT 结果之间的关系。在这项工作中，对已从 SARS-CoV-2 感染中康复的个体进行了四种不同的免疫测定（罗氏 Elecsys® Anti SARS-CoV-2 S、新柏 MAGLUMI® SARS-CoV-2 S-RBD IgG、新柏 MAGLUMI® 2019-nCoV IgG 和 EUROIMMUN® SARS-CoV-2 NeutraLISA 测定）。通过线性回归建模以及皮尔逊和斯皮尔曼系数的计算，探讨了每种测定与参考方法之间的相关性。此外，通过 ROC 曲线分析、科恩氏 Kappa 系数和阳性预测一致性评估了血清学检测区分具有高中和抗体滴度（>160）的样本的能力。EUROIMMUN® NeutraLISA 测定与 PRNT 结果的相关性最好（皮尔逊和斯皮尔曼系数分别为 0.660 和 0.784），ROC 曲线具有最高的准确性、灵敏度和特异性（分别为 0.857、0.889 和 0.829）。
