商业平台检测结果与接种后 SARS-CoV-2 中和抗体应答和临床宿主因素的相关性。
Correlation of a commercial platform's results with post-vaccination SARS-CoV-2 neutralizing antibody response and clinical host factors.
机构信息
Yale School of Medicine, New Haven, Connecticut, United States of America.
Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut, United States of America.
出版信息
PLoS One. 2023 Aug 29;18(8):e0289713. doi: 10.1371/journal.pone.0289713. eCollection 2023.
INTRODUCTION
The objective of this study was to describe the correlation between the commercially available assay for anti-S1/RBD IgG and protective serum neutralizing antibodies (nAb) against SARS-CoV-2 in an adult population after SARS-CoV-2 vaccination, and determine if clinical variables impact this correlation.
METHODS
We measured IgG anti-S1/RBD using the IgG-II CMIA assay and nAb IC50 values against SARS-CoV-2 WA-1 in sera serially collected post-mRNA vaccination in veterans and healthcare workers of the Veterans Affairs Connecticut Healthcare System (VACHS) between December 2020 and January 2022. The correlation between IgG and IC50 was measured using Pearson correlation. Clinical variables (age, sex, race, ethnicity, prior COVID infection defined by RT-PCR, history of malignancy, estimated glomerular filtration rate (GFR calculated using CKD-EPI equation) were collected by manual chart review. The impact of these clinical variables on the IgG-nAb correlation was analyzed first with univariable regression. Variables with a significance of p < 0.15 were analyzed with forward stepwise regression analysis.
RESULTS
From 127 sera samples in 100 unique subjects (age 20-93 years; mean 63.83; SD 15.63; 29% female; 67% White), we found a robust correlation between IgG anti-S1/RBD and nAb IC50 (R2 = 0.83, R2adj = 0.70, p < 0.0001). Race, ethnicity, and a history of malignancy were not significant on univariable analysis. GFR (p < 0.05) and prior COVID infection (p < 0.001) had a significant impact on the correlation between IgG anti-S1/RBD and nAb IC50. Age (p = 0.06) and sex (p = 0.07) trended towards significance on univariable analysis, but were not significant on multivariable regression.
CONCLUSIONS
There was a strong correlation between IgG anti-S1/RBD and nAb IC50 after SARS-CoV-2 vaccination. Clinical comorbidities, such as prior COVID infection and renal function, impacted this correlation. These results may assist the prediction of post-vaccination immune protection in clinical settings using cost-effective commercial platforms.
简介
本研究的目的是描述在接受 SARS-CoV-2 疫苗接种后，成年人中用于检测抗 S1/RBD IgG 的商业检测与针对 SARS-CoV-2 的保护性血清中和抗体（nAb）之间的相关性，并确定临床变量是否会影响这种相关性。
方法
我们使用 IgG-II CMIA 检测试剂盒测量 IgG 抗 S1/RBD，在 2020 年 12 月至 2022 年 1 月期间，在退伍军人事务部康涅狄格州医疗保健系统（VACHS）的退伍军人和医疗保健工作者中，对接受 mRNA 疫苗接种后的血清进行连续采集，以检测针对 SARS-CoV-2 WA-1 的 nAb IC50 值。使用 Pearson 相关性测量 IgG 与 IC50 值之间的相关性。通过手动图表审查收集临床变量（年龄、性别、种族、民族、通过 RT-PCR 定义的既往 COVID 感染、恶性肿瘤史、估计肾小球滤过率（使用 CKD-EPI 方程计算）。首先使用单变量回归分析这些临床变量对 IgG-nAb 相关性的影响。p < 0.15 的变量使用逐步向前回归分析进行分析。
结果
在 100 名个体的 127 份血清样本中（年龄 20-93 岁；平均 63.83；标准差 15.63；29%女性；67%白人），我们发现 IgG 抗 S1/RBD 与 nAb IC50 之间存在很强的相关性（R2 = 0.83，R2adj = 0.70，p < 0.0001）。在单变量分析中，种族、民族和恶性肿瘤史没有显著意义。肾小球滤过率（p < 0.05）和既往 COVID 感染（p < 0.001）对 IgG 抗 S1/RBD 与 nAb IC50 之间的相关性有显著影响。年龄（p = 0.06）和性别（p = 0.07）在单变量分析中呈趋势显著，但在多变量回归中无统计学意义。
结论
在接受 SARS-CoV-2 疫苗接种后，IgG 抗 S1/RBD 与 nAb IC50 之间存在很强的相关性。临床合并症，如既往 COVID 感染和肾功能，会影响这种相关性。这些结果可能有助于使用具有成本效益的商业平台在临床环境中预测疫苗接种后的免疫保护。
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