Laboratory Diagnostic Center, University Hospital RWTH Aachen, Germany.
Laboratory Diagnostic Center, University Hospital RWTH Aachen, Germany.
J Virol Methods. 2022 Jan;299:114297. doi: 10.1016/j.jviromet.2021.114297. Epub 2021 Sep 23.
Due to large vaccination efforts with novel vaccines there is an increasing need for laboratory tests assessing successful immunizations with SARS-CoV-2 vaccines. Unfortunately classical neutralization assays are laborious, time-consuming and require an adequate biosafety level laboratory. Recently, convenient ELISA-based surrogate neutralization assays (sVNTs) for determination of neutralizing SARS-CoV-2 antibodies have been developed.
Our study compares the two novel ELISA-based SARS-CoV-2 surrogate neutralization assays "cPass SARS-CoV-2 Surrogate Virus Neutralization Test Kit" (GenScript Biotech, USA) and the "TECO SARS-CoV-2 Neutralization Antibody Assay" (TECOmedical, Switzerland) using 93 sera drawn from health care workers (HCVs) 2-3 weeks following the second vaccination with mRNA-1273 and 40 control sera from the pre-SARS-CoV-2 era before 2019.
We found a sensitivity of 100% and 91,4% and a specificity of 100% and 100% for the GenScript assay and the TECO assay, respectively. Both sVNTs show a high correlation with anti-S IgG. Moreover, both sVNTs correlate well with each other.
Surrogate neutralization assays based on the RBD as bait feature a high specificity and sensitivity for identifying humoral neutralizing activity in individuals vaccinated with the spike-based vaccine mRNA-1273. Although these assays appear well-suited for confirming successful vaccinations with spike-based vaccines, additional studies should compare both assays regarding other purposes such as screening COVID-recovered patients or individuals vaccinated with inactivated whole virus vaccines.
由于新型疫苗的大规模接种,人们越来越需要实验室检测来评估 SARS-CoV-2 疫苗的免疫效果。不幸的是,经典的中和测定法既繁琐又耗时,且需要适当的生物安全级别实验室。最近,已经开发出了用于测定中和 SARS-CoV-2 抗体的方便的 ELISA 基于的替代中和测定法(sVNTs)。
我们的研究比较了两种新型基于 ELISA 的 SARS-CoV-2 替代中和测定法,即“cPass SARS-CoV-2 替代病毒中和测试试剂盒”(美国 GenScript Biotech)和“TECO SARS-CoV-2 中和抗体测定法”(瑞士 TECOmedical),使用了 93 份来自接种 mRNA-1273 疫苗后 2-3 周的医护人员(HCWs)的血清和 40 份来自 2019 年之前的 SARS-CoV-2 前时代的对照血清。
我们发现 GenScript 测定法的敏感性为 100%和 91.4%,特异性为 100%和 100%;TECO 测定法的敏感性为 100%和 91.4%,特异性为 100%和 100%。两种 sVNTs 与抗-S IgG 均具有高度相关性。此外,两种 sVNTs 彼此之间也具有良好的相关性。
基于 RBD 作为诱饵的替代中和测定法具有很高的特异性和敏感性,可用于鉴定接种基于 Spike 的疫苗 mRNA-1273 的个体中的体液中和活性。尽管这些测定法似乎非常适合确认基于 Spike 的疫苗的成功接种,但还需要进行更多的研究,比较这两种测定法在其他方面的用途,例如筛选 COVID 康复患者或接种灭活全病毒疫苗的个体。