验证 N 蛋白抗体用于诊断大批次医护人员既往 SARS-CoV-2 感染：罗氏 Elecsys 免疫分析法在 S 蛋白疫苗接种时代的应用。

Validation of N Protein Antibodies to Diagnose Previous SARS-CoV-2 Infection in a Large Cohort of Healthcare Workers: Use of Roche Elecsys Immunoassay in the S Protein Vaccination Era.

机构信息

Immunology Laboratory, Clinic Laboratories Service, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Departament de Medicina, Universitat Autònoma de Barcelona, 8207 Sabadell, Spain.

Epidemiology Service, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, 8207 Sabadell, Spain.

出版信息

Viruses. 2023 Apr 7;15(4):930. doi: 10.3390/v15040930.

DOI:10.3390/v15040930

PMID:37112910

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10146079/

Abstract

The aim of this study was to validate the detection of anti-nucleocapsid protein (N protein) antibodies for the diagnosis of SARS-CoV-2 infection in light of the fact that most COVID-19 vaccines use the spike (S) protein as the antigen. Here, 3550 healthcare workers (HCWs) were enrolled from May 2020 (when no S protein vaccines were available). We defined SARS-CoV-2 infection if HCWs were found to be positive by RT-PCR or found to be positive in at least two different serological immunoassays. Serum samples from Biobanc I3PT-CERCA were analyzed by Roche Elecsys (N protein) and Vircell IgG (N and S proteins) immunoassays. Discordant samples were reanalyzed with other commercial immunoassays. Roche Elecsys showed the positivity of 539 (15.2%) HCWs, 664 (18.7%) were found to be positive by Vircell IgG immunoassays, and 164 samples (4.6%) showed discrepant results. According to our SARS-CoV-2 infection criteria, 563 HCWs had SARS-CoV-2 infection. The Roche Elecsys immunoassay has a sensitivity, specificity, accuracy, and concordance with the presence of infection of 94.7%, 99.8%, 99.3%, and 0.96, respectively. Similar results were observed in a validation cohort of vaccinated HCWs. We conclude that the Roche Elecsys SARS-CoV-2 N protein immunoassay demonstrated good performance in diagnosing previous SARS-CoV-2 infection in a large cohort of HCWs.

摘要

本研究旨在验证抗核衣壳蛋白（N 蛋白）抗体检测在 SARS-CoV-2 感染诊断中的作用，因为大多数 COVID-19 疫苗都使用刺突（S）蛋白作为抗原。在这里，我们从 2020 年 5 月（当时尚无 S 蛋白疫苗）开始招募了 3550 名医护人员（HCWs）。如果 HCWs 通过 RT-PCR 检测呈阳性或至少两种不同的血清学免疫测定呈阳性，则定义为 SARS-CoV-2 感染。来自 Biobanc I3PT-CERCA 的血清样本通过罗氏 Elecsys（N 蛋白）和 Vircell IgG（N 和 S 蛋白）免疫测定进行分析。对不一致的样本用其他商业免疫测定进行重新分析。罗氏 Elecsys 显示 539 名（15.2%）HCWs 呈阳性，664 名（18.7%）HCWs 通过 Vircell IgG 免疫测定呈阳性，164 名（4.6%）样本显示不一致的结果。根据我们的 SARS-CoV-2 感染标准，有 563 名 HCWs 感染了 SARS-CoV-2。罗氏 Elecsys 免疫测定的灵敏度、特异性、准确性和与感染存在的一致性分别为 94.7%、99.8%、99.3%和 0.96。在接种疫苗的 HCWs 验证队列中观察到类似的结果。我们得出结论，罗氏 Elecsys SARS-CoV-2 N 蛋白免疫测定在诊断大量 HCWs 中先前的 SARS-CoV-2 感染方面表现出良好的性能。