Institute of Virology, Philipps University Marburg, Hans-Meerwein Str. 2, 35043, Marburg, Germany.
German Center for Infection Research (DZIF), Partner Site Gießen-Marburg-Langen, Marburg, Germany.
Med Microbiol Immunol. 2024 May 9;213(1):6. doi: 10.1007/s00430-024-00789-w.
To date, there is no licensed vaccine for Middle East respiratory syndrome coronavirus (MERS-CoV). Therefore, MERS-CoV is one of the diseases targeted by the Coalition for Epidemic Preparedness Innovations (CEPI) vaccine development programs and has been classified as a priority disease by the World Health Organization (WHO). An important measure of vaccine immunogenicity and antibody functionality is the detection of virus-neutralizing antibodies. We have developed and optimized a microneutralization assay (MNA) using authentic MERS-CoV and standardized automatic counting of virus foci. Compared to our standard virus neutralization assay, the MNA showed improved sensitivity when analyzing 30 human sera with good correlation of results (Spearman's correlation coefficient r = 0.8917, p value < 0.0001). It is important to use standardized materials, such as the WHO international standard (IS) for anti-MERS-CoV immunoglobulin G, to compare the results from clinical trials worldwide. Therefore, in addition to the neutralizing titers (NT = 1384, NT = 384), we determined the IC and IC of WHO IS in our MNA to be 0.67 IU/ml and 2.6 IU/ml, respectively. Overall, the established MNA is well suited to reliably quantify vaccine-induced neutralizing antibodies with high sensitivity.
迄今为止，中东呼吸综合征冠状病毒（MERS-CoV）还没有获得许可的疫苗。因此，MERS-CoV 是联盟疫苗研发计划（CEPI）针对的疾病之一，并被世界卫生组织（WHO）列为优先疾病。疫苗免疫原性和抗体功能的一个重要衡量标准是检测病毒中和抗体。我们使用真实的 MERS-CoV 开发并优化了一种微量中和测定法（MNA），并对病毒病灶进行了标准化自动计数。与我们的标准病毒中和测定法相比，MNA 在分析 30 份人类血清时具有更高的灵敏度，并且结果相关性良好（Spearman 相关系数 r=0.8917，p 值<0.0001）。使用标准化材料（例如，针对 MERS-CoV 免疫球蛋白 G 的世界卫生组织国际标准（IS））来比较全球临床试验的结果非常重要。因此，除了中和滴度（NT=1384，NT=384）外，我们还确定 MNA 中 WHO IS 的 IC 和 IC 分别为 0.67 IU/ml 和 2.6 IU/ml。总的来说，建立的 MNA 非常适合可靠地定量检测疫苗诱导的中和抗体，具有很高的灵敏度。
