Research and Development Immunoassays, Roche Diagnostics GmbH, Penzberg, Germany.
Biostatistics & Data Science, Roche Diagnostics GmbH, Penzberg, Germany.
Front Immunol. 2022 Dec 2;13:1002576. doi: 10.3389/fimmu.2022.1002576. eCollection 2022.
Automated, high throughput assays are required to quantify the immune response after infection with or vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study on the Roche Elecsys Anti-SARS-CoV-2 S (ACOV2S) assay provides insights on the assay design and performance.
The ACOV2S assay quantifies antibodies to the receptor-binding domain of the SARS-CoV-2 spike protein. The assigned units and the underlying standardization were compared to the international reference standard in BAU/mL. Assay specificity was assessed in samples (n=5981) collected prior to the COVID-19 pandemic and in samples from patients with non-COVID-19 respiratory infections (n=697) or other infectious diseases (n=771). Sensitivity was measured in 1313 samples from patients with mild COVID-19 and 297 samples from patients hospitalized with COVID-19. Comparison of results was performed to a comparator semi-quantitative anti-S1 assay of indirect detection format as well as a commercially available and an in-house version of a surrogate neutralization assay (ACE2-RBD).
The originally assigned units for the ACOV2S assay were shown to be congruent to the units of the First International WHO Standard for anti-SARS-CoV-2 immunoglobulins. Overall specificity was 99.98% with no geographical differences noted and no loss of specificity in samples containing potentially cross-reacting antibodies. High sensitivity was observed, with 98.8% of samples reported to be reactive >14 days after infection and sustained detection of antibodies over time. For all samples, ACOV2S titers and neutralization capacities developed with comparable dynamics. Robust standardization and assay setup enable excellent reproducibility of results, independent of lot or analyzer used.
The results from this study confirmed that ACOV2S is a highly sensitive and specific assay and correlates well with surrogate neutralization assays. The units established for ACOV2S are also interchangeable with the units of the First International WHO Standard for anti-SARS-CoV-2 immunoglobulins. Worldwide availability of the assay and analyzers render ACOV2S a highly practical tool for population-wide assessment and monitoring of the humoral response to SARS-CoV-2 infection or vaccination.
为了量化感染严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）或接种 SARS-CoV-2 疫苗后的免疫反应，需要自动化、高通量的检测方法。本研究对罗氏 Elecsys Anti-SARS-CoV-2 S（ACOV2S）检测方法进行了评估，提供了关于检测方法设计和性能的见解。
ACOV2S 检测方法定量检测 SARS-CoV-2 刺突蛋白受体结合域的抗体。所分配的单位和基础标准化与 BAU/mL 国际参考标准进行了比较。在 COVID-19 大流行之前收集的样本（n=5981）和患有非 COVID-19 呼吸道感染（n=697）或其他传染病（n=771）的患者样本中评估了检测方法的特异性。在 1313 例轻度 COVID-19 患者和 297 例 COVID-19 住院患者的样本中测量了敏感性。将结果与间接检测格式的半定量抗 S1 比较检测方法、一种商业上可用的和一种内部替代中和检测方法（ACE2-RBD）进行了比较。
显示 ACOV2S 检测方法的原始分配单位与第一份国际世界卫生组织 SARS-CoV-2 免疫球蛋白标准单位一致。总体特异性为 99.98%，没有发现地理差异，也没有在含有潜在交叉反应抗体的样本中特异性丧失。观察到高灵敏度，有 98.8%的样本在感染后 14 天以上报告为阳性，并随着时间的推移持续检测到抗体。对于所有样本，ACOV2S 滴度和中和能力以相似的动态发展。稳健的标准化和检测设置使结果具有出色的重现性，与使用的批次或分析仪无关。
本研究结果证实，ACOV2S 是一种高度敏感和特异性的检测方法，与替代中和检测方法相关性良好。为 ACOV2S 建立的单位也与第一份国际世界卫生组织 SARS-CoV-2 免疫球蛋白标准单位可互换。该检测方法和分析仪在全球范围内的可用性使 ACOV2S 成为一种非常实用的工具，可用于人群中 SARS-CoV-2 感染或接种疫苗后对体液免疫反应的评估和监测。
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