评估一种基于即时检测的侧向流动测定法，用于检测 SARS CoV-2 mRNA 疫苗系列接种后的抗体。
Evaluation of a point of care lateral flow assay for antibody detection following SARS CoV-2 mRNA vaccine series.
机构信息
Department of Anesthesia and Perioperative Care, University of California - San Francisco, San Francisco, CA, USA.
Department of Anesthesia and Perioperative Care, University of California - San Francisco, San Francisco, CA, USA; Zuckerberg San Francisco General Hospital, San Francisco, CA, USA.
出版信息
J Immunol Methods. 2023 Feb;513:113410. doi: 10.1016/j.jim.2022.113410. Epub 2022 Dec 29.
BACKGROUND
Breakthrough cases of SARS-CoV-2 infection correlate with decreased antibody immunity following mRNA vaccination. Measuring kinetics of vaccine efficacy using traditional laboratory approaches is more expensive and can be impractical. In this study, we evaluated the diagnostic performance of a validated COVID-19 point-of-care lateral flow assay (LFA) kit in detecting post-vaccination antibody response.
METHODS
We conducted a prospective cohort study of whole blood and plasma samples to evaluate the performance of a LFA in detecting SARS-CoV-2-specific antibodies following mRNA vaccination compared to enzyme-linked immunosorbent assays (ELISAs). Health care workers at 2 tertiary centers who completed an initial BNT162b2 (n = 103) or mRNA-1273 (n = 35) vaccine series were enrolled between June and August of 2021. We performed an exploratory analysis to correlate band strength and antibody concentration of LFAs and ELISAs respectively.
RESULTS
When compared to the ELISA, LFA results showed similar test positivity for plasma samples (P = 0.55), but not for whole blood samples (P < 0.001). For whole blood samples on the LFA, antibody detection differed between BNT162b2 (68.9%, 95% CI: 59.1%-77.7%) and mRNA-1273 (100%, 95% CI: 90.0%-100%, P < 0.001) vaccines. Higher plasma antibody concentrations correlated with greater LFA sensitivity. Samples with thick LFA bands had higher antibody concentrations compared to samples having faint LFA bands (81.8 arbitrary unit [AU]/mL vs. 57.1 AU/mL, P < 0.01).
CONCLUSIONS
The performance of a LFA in detecting SARS-CoV-2 antibodies was significantly better when plasma samples were used. The strength of label bands on the LFA may correlate with antibody concentration and could be a useful point-of-care monitoring tool for post-vaccine antibody status.
背景
SARS-CoV-2 突破性感染病例与 mRNA 疫苗接种后抗体免疫下降有关。使用传统实验室方法测量疫苗效力的动力学更加昂贵且不切实际。在这项研究中，我们评估了一种经过验证的 COVID-19 即时护理侧向流动检测（LFA）试剂盒在检测 mRNA 疫苗接种后抗体反应方面的诊断性能。
方法
我们进行了一项前瞻性队列研究，使用全血和血浆样本评估 LFA 检测 mRNA 疫苗接种后 SARS-CoV-2 特异性抗体的性能，并与酶联免疫吸附测定（ELISA）进行比较。2021 年 6 月至 8 月，在 2 个三级中心完成初始 BNT162b2（n=103）或 mRNA-1273（n=35）疫苗系列接种的医护人员入组。我们进行了一项探索性分析，分别比较 LFA 和 ELISA 的条带强度与抗体浓度的相关性。
结果
与 ELISA 相比，LFA 结果对血浆样本的检测阳性率相似（P=0.55），但对全血样本的检测阳性率不同（P<0.001）。对于 LFA 的全血样本，BNT162b2（68.9%，95%CI：59.1%-77.7%）和 mRNA-1273（100%，95%CI：90.0%-100%，P<0.001）疫苗之间的抗体检测存在差异。较高的血浆抗体浓度与 LFA 敏感性增加相关。与 LFA 条带较浅的样本相比，LFA 条带较厚的样本具有更高的抗体浓度（81.8 个任意单位[AU]/mL 比 57.1 AU/mL，P<0.01）。
结论
当使用血浆样本时，LFA 检测 SARS-CoV-2 抗体的性能显著提高。LFA 上标签条带的强度可能与抗体浓度相关，并且可能是疫苗接种后抗体状态的有用即时护理监测工具。
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