Oksanich, A. S.;
Krasko, A. G.;
Samartseva, T. G.;
Gasich, E. L.;
Ignatyev, G. M.
The use of quantitative enzyme-linked immunosorbent assay for the determination of S-antigen concentration in whole-virion inactivated adsorbed coronavirus vaccines
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Media type:
E-Article
Title:
The use of quantitative enzyme-linked immunosorbent assay for the determination of S-antigen concentration in whole-virion inactivated adsorbed coronavirus vaccines
Contributor:
Oksanich, A. S.;
Krasko, A. G.;
Samartseva, T. G.;
Gasich, E. L.;
Ignatyev, G. M.
imprint:
SCEEMP, 2022
Published in:Biological Products. Prevention, Diagnosis, Treatment
Description:
<jats:p>The severe consequences and high mortality of COVID-19 prompted the development of a wide range of preventive vaccines. The first vaccines to be tested were developed in China and formulated as inactivated SARS-CoV-2 adsorbed on aluminium hydroxide. One of the quality indicators for inactivated adsorbed vaccines is the degree of adsorption, which can be used to control the content not only of non-adsorbed antigen, but also of specific antigen in one dose of a vaccine.</jats:p><jats:p><jats:bold>The aim</jats:bold> <jats:bold>of the study </jats:bold>was to investigate the possibility of desorbing SARS-CoV-2 antigen from formulated adsorbed vaccines and the possibility of measuring its concentration using the BioScan-SARS-CoV-2 (S) ELISA kit for SARS-CoV-2 S-protein content determination.</jats:p><jats:p><jats:bold>Materials and methods:</jats:bold> the study used four batches of BBIBP-CorV by CNBG, Sinopharm (China) and three batches of CoronaVac by Sinovac Biotech (China). The authors desorbed SARS-CoV-2 S antigen in accordance with monograph FS.3.3.1.0029.15 of the State Pharmacopoeia of the Russian Federation (Ph. Rus.), edition XIV, and quantified it using the BioScan-SARS-CoV-2 (S) ELISA kit by Bioservice Biotechnology Co. Ltd. (Russia).</jats:p><jats:p><jats:bold>Results:</jats:bold> mean S-antigen concentrations in the desorbed samples ranged from 61 to 129 ng/mL for BBIBP-CorV and from 461 to 533 ng/mL for CoronaVac.</jats:p><jats:p><jats:bold>Conclusions: </jats:bold>the study demonstrated the possibility of specific SARS-CoV-2 antigen desorption from the surface of aluminium hydroxide using the Ph. Rus. method, as well as the possibility of S-antigen quantification in desorbed medicinal products and supernatants using the BioScan-SARS-CoV-2 (S) ELISA kit. The authors observed 3.6- to 8.7-fold difference between the S-antigen concentrations of the desorbed preparations by the two manufacturers.</jats:p>