Quantitative Immunological Assays to Assess SARS-CoV-2 Antibodies and Vaccines

在过去几年中，病毒学实验室与其他NIAID内部实验室和其他外部合作者合作，开发了一种假病毒中和试验和一种表达增殖稳定的SARS-CoV-2刺突三聚体（mRNA-1273）的mRNA疫苗。对于中和试验，我们向其他VRC实验室提供了技术和软件协助，并制定了共享的标准操作程序。由于世界上不断出现更多新的SARS-CoV-2变型病毒，我们也在不断制作各种与新出现的变型病毒相对应的假病毒。更重要的是，伪病毒中和实验还需要进行修改，以适应新的变异病毒，使实验适合使用。实验室工作人员正在使用该检测方法来评估从COVID-19康复的个人和政府批准的疫苗临床试验志愿者的人类血清样本。我们还从COVID-19疾病恢复期个体中分离和鉴定单克隆抗体，评估SARS-CoV-2中和抗体，这些抗体是有价值的研究试剂，在治疗和预防不断出现的SARS-CoV-2变体方面具有巨大潜力。

During the past years, the Virology Laboratory has collaborated with other intramural NIAID labs and other external collaborators to develop a pseudovirus neutralization assay and an mRNA vaccine expressing the prefusion-stabilized SARS-CoV-2 spike trimer (mRNA-1273). For the neutralization assay, we have provided technical and software assistance to other VRC labs, and developed a shared Standard Operating Procedure. Since more new SARS-CoV-2 variant viruses continuously arise in the world, we are continuously making various pseudoviruses corresponding to the emerging variant viruses. And more importantly, the pseudovirus neutralization assay also needed to be modified to adapted to the new variant viruses for the assay appropriate usage. The assay is being used by laboratory staff to evaluate human serum samples from individuals recovering from COVID-19 and from volunteers in the clinical trial of the government approved vaccines. We are also isolating and characterizing monoclonal antibodies from individuals recovering from COVID-19 disease, assessing for SARS-CoV-2 neutralizing antibodies, which are valuable research reagents with great potential for therapeutic and prevention purposes against the continuously emerging SARS-CoV-2 variants. By using this powerful assay, we have analyzed the potency and cross-reactivity of anti-COVID-19 antibodies in the blood of vaccinated or infected individuals. Specifically, we have measured neutralizing antibodies against the original or variant SARS-CoV-2 viruses as part of clinical trials for mRNA vaccines. We have also assessed the neutralization activity of monoclonal antibodies isolated from individuals who have recovered from COVID-19, as part of our basic research on viral immunity, and in search of monoclonal antibodies with preventative or therapeutic potential.