In the process of developing a COVID-19 hyper- immune globulin (COVID-19 HIG), one of the tasks was to choose a method for determining the content of antibodies to SARS-CoV-2. Determining the antibody titer in the virus neutralization test (VNT) is laborious and does not allow to scale up. The development of an accessible method of standardization solves the issues of routine use. Due to the lack of international reference standards (RS) and gold standard method, it became necessary to develop potency test for quality control of HIG. We studied the possibility of replacing the VNT method with ELISA and developed potency test for COVID-19 HIG standardization using ELISA. We tested 1499 samples of human blood plasma by virus neutralization reactions, and enzyme immunoassay, chemiluminescent immunoassay on microparticles with commercial ELISA kits from various manufacturers. We found correlation between results from VNT and ELISA kits produced by the NRC for Hematology of the MOH and Euroimmun AG that showed the possibility of using ELISA instead of RVN. We also developed reference standards to validate selected assays for the quantification of antibodies to SARS-CoV-2. To assess potency, we used new units of measurement - anticovid units and harmonized them with antibody binding units (BAU) when the WHO international reference panel (code NIBSC 20/268) appeared. The developed method for determining potency can be used to assess potency in raw materials (plasma) and COVID-19 HIG. The method helped develop a COVID-19 HIG that successfully passed clinical trials. More than 50 batches of COVID-19 HIG have been produced using the method.

Tatiana Smolyanova has completed his PHD at the age of 38 years in Russia. She is the head of department of special projects in Nacimbio JSC, Russia. He has over 20 publications that have been cited over 700 times, and her publication h-index is 5. She has been serving as an editorial board member of several journals. Under her leadership, a specific human immunoglobulin preparation for the treatment of COVID-19 was developed.