Introduction: Commercially available SARS-CoV-2 serological assays based on different viral antigens have been approved for the qualitative determination of anti-SARS-CoV-2 antibodies. However, there is limited published data associating the results from commercial assays with neutralizing antibodies. Methods: 67 specimens from 48 patients with PCR-confirmed COVID-19 and a positive result by the Roche Elecsys SARS-CoV-2, Abbott SARS-CoV-2 IgG, or EUROIMMUN SARS-CoV-2 IgG assays and 5 control specimens were analyzed for the presence of neutralizing antibodies to SARS-CoV-2. Correlation, concordance, positive percent agreement (PPA), and negative percent agreement (NPA) were calculated at several cutoffs. Results were compared in patients categorized by clinical outcomes. Results: The correlation between SARS-CoV-2 neutralizing titer (EC50) and the Roche, Abbott, and EUROIMMUN assays was 0.29, 0.47, and 0.46 respectively. At an EC50 of 1:32, the concordance kappa with Roche was 0.49 (95% CI; 0.23-0.75), with Abbott was 0.52 (0.28-0.77), and with EUROIMMUN was 0.61 (0.4-0.82). At the same neutralizing titer, the PPA and NPA for the Roche was 100% (94-100) & 56% (30-80); Abbott was 96% (88-99) & 69% (44-86); and EUROIMMUN was 91% (80-96) & 81% (57-93) for distinguishing neutralizing antibodies. Patients who died, were intubated, or had a cardiac injury from COVID-19 infection had significantly higher neutralizing titers relative to those with mild symptoms. Conclusion: COVID-19 patients generate an antibody response to multiple viral proteins such that the calibrator ratios on the Roche, Abbott, and EUROIMMUN assays are all associated with SARS-CoV-2 neutralization. Nevertheless, commercial serological assays have poor NPA for SARS-CoV-2 neutralization, making them imperfect proxies for neutralization.

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抗SARS-CoV-2中和抗体与商业血清学检测之间的关联

简介：已批准基于不同病毒抗原的市售SARS-CoV-2血清学检测方法用于定性测定抗SARS-CoV-2抗体。然而，有限的公开数据将商业测定的结果与中和抗体相关联。方法：从48例经PCR确认的COVID-19患者中获得67份标本，并通过Roche Elecsys SARS-CoV-2，Abbott SARS-CoV-2 IgG或EUROIMMUN SARS-CoV-2 IgG测定获得阳性结果，并作为5份对照标本分析了针对SARS-CoV-2的中和抗体的存在。在几个临界点处计算了相关性，一致性，一致百分比（PPA）和一致百分比（NPA）。比较了按临床结果分类的患者的结果。结果：SARS-CoV-2中和效价（EC50）与Roche，Abbott和EUROIMMUN分析之间的相关性分别为0.29、0.47和0.46。当EC50为1:32时，与罗氏（Roche）的一致性kappa为0.49（95％CI; 0.23-0.75），与雅培（Abbott）的一致性kappa为0.52（0.28-0.77），与EUROIMMUN的一致性kappa为0.61（0.4-0.82）。在相同的中和效价下，罗氏的PPA和NPA为100％（94-100）和56％（30-80）；雅培为96％（88-99）和69％（44-86）；而EUROIMMUN在区分中和抗体方面分别为91％（80-96）和81％（57-93）。与轻症患者相比，因COVID-19感染死亡，被插管或因心脏受伤的患者的中和滴度明显更高。结论：COVID-19患者产生针对多种病毒蛋白的抗体反应，因此Roche，Abbott，和EUROIMMUN分析均与SARS-CoV-2中和有关。然而，商业血清学检测的NPA对于SARS-CoV-2中和作用较差，使其不完全代表中和作用。