As the coronavirus disease 2019 (COVID-19) pandemic second wave is emerging, it is of the upmost importance to screen the population immunity in order to keep track of infected individuals. Consequently, immunoassays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with high specificity and positive predictive values are needed to obtain an accurate epidemiological picture. As more data accumulate about the immune responses and the kinetics of neutralizing-antibody (nAb) production in SARS-CoV-2-infected individuals, new applications are forecast for serological assays such as nAb activity prediction in convalescent-phase plasma from recovered patients. This multicenter study, involving six hospital centers, determined the baseline clinical performances, reproducibility, and nAb level correlations of 10 commercially available immunoassays. In addition, three lateral-flow chromatography assays were evaluated, as these devices can be used in logistically challenged areas. All assays were evaluated using the same patient panels in duplicate, thus enabling accurate comparison of the tests. Seven immunoassays examined in this study were shown to have excellent specificity (98 to 100%) and good to excellent positive predictive values (82 to 100%) when used in a low (5%)-seroprevalence setting. We observed sensitivities as low as 74% and as high as 95% at ≥15 days after symptom onset. The determination of optimized cutoff values through receiver operating characteristic (ROC) curve analyses had a significant impact on the diagnostic resolution of several enzyme immunoassays by increasing the sensitivity significantly without a large trade-off in specificity. We found that spike-based immunoassays seem to be better correlates of nAb activity. Finally, the results reported here will add to the general knowledge of the interlaboratory reproducibility of clinical performance parameters of immunoassays and provide new evidence about nAb activity prediction.

中文翻译：

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临床实验室使用的10种高通量血清学检测方法的临床性能和中和抗体活性预测特性的多中心评估

随着2019年冠状病毒病（COVID-19）大流行的第二波浪潮的到来，筛选人群免疫力以追踪感染的个体至关重要。因此，需要获得具有高特异性和阳性预测值的重症急性呼吸综合征冠状病毒2（SARS-CoV-2）的免疫分析方法，以获得准确的流行病学图像。随着有关SARS-CoV-2感染个体中免疫应答和中和抗体（nAb）产生动力学的数据积累，预测了血清学检测的新应用，例如恢复患者血浆恢复期血浆中的nAb活性预测。这项涉及六个医院中心的多中心研究确定了基线临床表现，可重复性，和10种市售免疫测定的nAb水平相关性。此外，评估了三种侧流色谱分析，因为这些设备可用于后勤困难地区。所有测定均使用相同的患者组进行一式两份评估，从而能够准确比较测试结果。在低（5％）血清阳性率的环境中使用时，本研究中检验的7种免疫分析方法具有出色的特异性（98％至100％）和良好至出色的阳性预测值（82％至100％）。我们在症状发作后≥15天观察到敏感性低至74％和高至95％。通过接收器工作特性（ROC）曲线分析确定最佳临界值，可以通过显着提高灵敏度而无需大幅度权衡取舍，对几种酶免疫测定的诊断分辨率产生重大影响。我们发现基于尖峰的免疫分析似乎与nAb活性具有更好的相关性。最后，此处报告的结果将增加免疫测定的临床性能参数在实验室间可重复性方面的常识，并提供有关nAb活性预测的新证据。