商业平台检测到的 SARS-CoV-2 血清学状态可区分既往感染和疫苗接种的适应性免疫反应。

SARS-CoV-2 Serology Status Detected by Commercialized Platforms Distinguishes Previous Infection and Vaccination Adaptive Immune Responses.

机构信息

Department of Pathology, UC San Diego Health, San Diego, CA.

Department of Immunology and Microbiology, The Scripps Research Institution, San Diego, CA.

出版信息

J Appl Lab Med. 2021 Sep 1;6(5):1109-1122. doi: 10.1093/jalm/jfab080.

DOI:10.1093/jalm/jfab080

PMID:34170314

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8409063/

Abstract

BACKGROUND

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has infected over 110 million individuals and led to 2.5 million deaths worldwide. As more individuals are vaccinated, the clinical performance and utility of SARS-CoV-2 serology platforms needs to be evaluated.

METHODS

The ability of 4 commercial SARS-CoV-2 serology platforms to detect previous infection or vaccination were evaluated using a cohort of 53 patients who were SARS-CoV-2 PCR positive, 89 SARS-CoV-2-vaccinated healthcare workers (Pfizer or Moderna), and 127 patients who were SARS-CoV-2 negative. Serology results were compared to a cell-based SARS-CoV-2 pseudovirus (PSV) neutralizing antibodies assay.

RESULTS

The Roche S-(spike) antibody and Diazyme neutralizing antibodies (NAbs) assays detected adaptive immune response in 100.0% and 90.1% of vaccinated individuals who received 2 doses of vaccine (initial and booster), respectively. The Roche N-(nucleocapsid) antibody assay and Diazyme IgG assay did not detect adaptive immune response in vaccinated individuals. The Diazyme NAbs assay correlated with the PSV SARS-CoV-2 median infective dose (ID50) neutralization titers (R2 = 0.70), while correlation of the Roche S-antibody assay was weaker (R2 = 0.39). Median PSV SARS-CoV-2 ID50 titers more than doubled in vaccinated individuals who received 2 doses of the Moderna vaccine (ID50, 597) compared to individuals who received a single dose (ID50, 284).

CONCLUSIONS

The Roche S-antibody and Diazyme NAbs assays robustly detected adaptive immune responses in SARS-CoV-2 vaccinated individuals and SARS-CoV-2 infected individuals. The Diazyme NAbs assay strongly correlates with the PSV SARS-CoV-2 NAbs in vaccinated individuals. Understanding the reactivity of commercially available serology platforms is important when distinguishing vaccination response versus natural infection.

摘要

背景

严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）已感染超过 1.1 亿人，导致全球 250 万人死亡。随着越来越多的人接种疫苗，需要评估 SARS-CoV-2 血清学平台的临床性能和实用性。

方法

使用 53 名 SARS-CoV-2 PCR 阳性患者、89 名 SARS-CoV-2 疫苗接种医护人员（辉瑞或 Moderna）和 127 名 SARS-CoV-2 阴性患者的队列，评估了 4 种商业 SARS-CoV-2 血清学平台检测既往感染或接种疫苗的能力。将血清学结果与基于细胞的 SARS-CoV-2 假病毒（PSV）中和抗体测定进行比较。

结果

罗氏 S（刺突）抗体和 Diazyme 中和抗体（NAb）检测到分别接受 2 剂疫苗（初始和加强剂）的接种者中 100.0%和 90.1%的适应性免疫反应。罗氏 N（核衣壳）抗体检测和 Diazyme IgG 检测均未检测到接种者的适应性免疫反应。Diazyme NAb 检测与 PSV SARS-CoV-2 中值感染剂量（ID50）中和滴度（R2=0.70）相关，而罗氏 S 抗体检测的相关性较弱（R2=0.39）。与接种一剂 Moderna 疫苗的个体（ID50，284）相比，接受两剂 Moderna 疫苗的个体的 PSV SARS-CoV-2 ID50 滴度增加了一倍以上（ID50，597）。

结论

罗氏 S 抗体和 Diazyme NAb 检测在 SARS-CoV-2 接种者和 SARS-CoV-2 感染者中可靠地检测到适应性免疫反应。Diazyme NAb 检测与接种者的 PSV SARS-CoV-2 NAb 强烈相关。了解商业上可用的血清学平台的反应性对于区分疫苗接种反应与自然感染非常重要。