SARS-CoV-2 serosurveys can estimate cumulative incidence for monitoring epidemics but require characterization of employed serological assays performance to inform testing algorithm development and interpretation of results. We conducted a multi-laboratory evaluation of 21 commercial high-throughput SARS-CoV-2 serological assays using blinded panels of 1,000 highly-characterized blood-donor specimens. Assays demonstrated a range of sensitivities (96%-63%), specificities (99%-96%) and precision (IIC 0.55-0.99). Durability of antibody detection in longitudinal samples was dependent on assay format and immunoglobulin target, with anti-spike, direct, or total Ig assays demonstrating more stable, or increasing reactivity over time than anti-nucleocapsid, indirect, or IgG assays. Assays with high sensitivity, specificity and durable antibody detection are ideal for serosurveillance. Less sensitive assays demonstrating waning reactivity are appropriate for other applications, including characterizing antibody responses after infection and vaccination, and detection of anamnestic boosting by reinfections and vaccine breakthrough infections. Assay performance must be evaluated in the context of the intended use.

中文翻译：

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用于血清监测和相关应用的市售高通量 SARS-CoV-2 血清学检测的评估

SARS-CoV-2 血清调查可以估计用于监测流行病的累积发生率，但需要表征所采用的血清学检测性能，以告知测试算法的开发和结果的解释。我们使用由 1,000 个高度表征的献血者样本组成的盲板对 21 种商业高通量 SARS-CoV-2 血清学检测进行了多实验室评估。分析显示了一系列灵敏度 (96%-63%)、特异性 (99%-96%) 和精确度 (IIC 0.55-0.99)。纵向样本中抗体检测的持久性取决于检测形式和免疫球蛋白靶标，与抗核衣壳、间接或 IgG 检测相比，抗尖峰、直接或总 Ig 检测表现出更稳定或随时间增加的反应性。检测灵敏度高，特异性和持久的抗体检测是血清监测的理想选择。证明反应性减弱的不太敏感的测定适用于其他应用，包括表征感染和疫苗接种后的抗体反应，以及通过再感染和疫苗突破感染检测记忆增强。必须在预期用途的背景下评估检测性能。