Emerg Infect Dis. 2022 Mar;28(3):672-683. doi: 10.3201/eid2803.211885.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serosurveys can estimate cumulative incidence for monitoring epidemics, requiring assessment of serologic assays to inform testing algorithm development and interpretation of results. We conducted a multilaboratory evaluation of 21 commercial high-throughput SARS-CoV-2 serologic assays using blinded panels of 1,000 highly characterized specimens. Assays demonstrated a range of sensitivities (96%-63%), specificities (99%-96%), and precision (intraclass correlation coefficient 0.55-0.99). Durability of antibody detection was dependent on antigen and immunoglobulin targets; antispike and total Ig assays demonstrated more stable longitudinal reactivity than antinucleocapsid and IgG assays. Assays with high sensitivity, specificity, and durable antibody detection are ideal for serosurveillance, but assays demonstrating waning reactivity are appropriate for other applications, including correlation with neutralizing activity and detection of anamnestic boosting by reinfections. Assay performance must be evaluated in context of intended use, particularly in the context of widespread vaccination and circulation of SARS-CoV-2 variants.
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）血清学调查可估算累计发病率以监测疫情，这需要评估血清学检测方法，以确定检测算法的开发，并解释检测结果。我们使用 1000 个经过高度特征化的样本的盲法检测组，对 21 种商业高通量 SARS-CoV-2 血清学检测方法进行了多实验室评估。检测方法的灵敏度范围为 96%-63%，特异性为 99%-96%，精密度为 0.55-0.99（组内相关系数）。抗体检测的持久性取决于抗原和免疫球蛋白靶标；与抗核衣壳和 IgG 检测相比，抗刺突和总 Ig 检测具有更稳定的纵向反应性。具有高灵敏度、特异性和持久抗体检测的检测方法非常适合血清学监测，但反应性逐渐减弱的检测方法也适用于其他应用，包括与中和活性的相关性以及通过再次感染检测记忆性增强。检测方法的性能必须在预期用途的背景下进行评估，特别是在广泛接种疫苗和 SARS-CoV-2 变体传播的背景下。
