The use of quantitative enzyme-linked immunosorbent assay for the determination of S-antigen concentration in whole-virion inactivated adsorbed coronavirus vaccines

The severe consequences and high mortality of COVID-19 prompted the development a wide range preventive vaccines. first vaccines to be tested were developed in China formulated as inactivated SARS-CoV-2 adsorbed on aluminium hydroxide. One quality indicators for is degree adsorption, which can used control content not only non-adsorbed antigen, but also specific antigen one dose vaccine. aim study was investigate possibility desorbing from measuring its concentration using BioScan-SARS-CoV-2 (S) ELISA kit S-protein determination. Materials methods: four batches BBIBP-CorV by CNBG, Sinopharm (China) three CoronaVac Sinovac Biotech (China). authors desorbed S accordance with monograph FS.3.3.1.0029.15 State Pharmacopoeia Russian Federation (Ph. Rus.), edition XIV, quantified it Bioservice Biotechnology Co. Ltd. (Russia). Results: mean S-antigen concentrations samples ranged 61 129 ng/mL 461 533 CoronaVac. Conclusions: demonstrated desorption surface hydroxide Ph. Rus. method, well quantification medicinal products supernatants kit. observed 3.6- 8.7-fold difference between preparations two manufacturers.