Laboratoire Alphabio-Biogroup, Marseille, France.
Department of Infectious Diseases and Internal Medicine, Hôpital Européen, Marseille, France.
PLoS One. 2023 Apr 28;18(4):e0281257. doi: 10.1371/journal.pone.0281257. eCollection 2023.
Identifying a specific threshold level of SARS-CoV-2 antibodies that confers protection in immunocompromised patients has been very challenging. The aim was to assess the threshold of 264 binding antibody units (BAU)/ml using four different SARS-CoV-2 antibody assays (Abbott, Beckman, Roche, and Siemens) and to establish a new optimal threshold of protection for each of the four antibody assays.
This study was performed on data retrieved from 69 individuals, who received at least one dose of the Pfizer/BioNTech BNT162b2 or Moderna COVID-19 vaccine (Spikevax) at the Alphabio Laboratory in Marseille, France (European Hospital, Alphabio-Biogroup). The results were compared to the percent inhibition calculated using a functional surrogate of a standardized virus neutralization test (Genscript).
Samples from 69 patients were analyzed. For a reference cutoff of 264 BAU/ml, assays showed moderate to good overall concordance with Genscript: 87% concordance for Abbott, 78% for Beckman, 75% for Roche, and 88% for Siemens. Overall concordance increased consistently after applying new thresholds, i.e., 148 BAU/ml (Abbott), 48 (Beckman), 559 (Roche), and 270 (Siemens).
We suggest specific adjusted thresholds (BAU/ml) for the four commercial antibody assays that are used to assess pre-exposure prophylaxis in immunocompromised patients.
确定赋予免疫功能低下患者保护作用的 SARS-CoV-2 抗体的特定阈值水平极具挑战性。本研究旨在评估使用四种不同 SARS-CoV-2 抗体检测试剂盒（雅培、贝克曼、罗氏和西门子）的 264 结合抗体单位（BAU）/ml 阈值，并为这四种抗体检测试剂盒确定新的最佳保护阈值。
本研究使用来自法国马赛 Alphabio 实验室（欧洲医院，Alphabio-Biogroup）的 69 名至少接受过一剂辉瑞/生物技术公司 BNT162b2 或 Moderna COVID-19 疫苗（Spikevax）的个体的数据进行分析。结果与使用标准化病毒中和试验（Genscript）的功能性替代物计算的抑制百分比进行比较。
分析了 69 名患者的样本。对于 264 BAU/ml 的参考截止值，检测试剂盒与 Genscript 显示出中等至良好的总体一致性：雅培的一致性为 87%，贝克曼的一致性为 78%，罗氏的一致性为 75%，西门子的一致性为 88%。应用新阈值后，总体一致性一致增加，即 148 BAU/ml（雅培）、48 BAU/ml（贝克曼）、559 BAU/ml（罗氏）和 270 BAU/ml（西门子）。
我们建议对用于评估免疫功能低下患者暴露前预防的四种商业抗体检测试剂盒使用特定的调整后的阈值（BAU/ml）。
