FIELD: chemical-pharmaceutical industry.
SUBSTANCE: described is a method for quantitative determination of S-antigen concentration by enzyme immunoassay in a vaccine, selected from a group of whole-virion inactivated adsorbed on aluminum hydroxide, subunit based on S-protein, recombinant or polypeptide, containing the RBD receptor-binding domain of the S-protein of the SARS-CoV virus separately, as part of the S1 subunit or in the full-length S-protein of the SARS-CoV virus, which is intended for the prevention of coronavirus infections. Enzyme immunoassay is carried out using two types of monoclonal antibodies specific to the receptor-binding domain of the RBD S-protein of the SARS-CoV virus, recognizing different non-overlapping epitopes of the RBD receptor-binding domain of the S-protein of the SARS-CoV virus, capable of detecting at least one specific strain of the SARS-CoV virus, not interacting with other strains of SARS-CoV virus. At least one antibody is sorbed on a polystyrene plate and is a first type antibody, at least one antibody is conjugated with a ligand and is an antibody of the second type. Also described is the use of said method for quality control of the vaccine.
EFFECT: invention makes it possible to considerably simplify, considerably reduce time of production of vaccine preparations, to reduce cost of carrying out of necessary tests and researches with preservation of quality characteristic for in vivo tests.
12 cl, 3 dwg, 7 ex
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