Article
Establishment and validation of an ELISA for the quantitation of HBsAg in recombinant hepatitis B vaccines
Registro en:
COSTA, Catia Inês; et al. Establishment and validation of an ELISA for the quantitation of HBsAg in recombinant hepatitis B vaccines. Journal of Virological Methods, v.172, p.32-37, Dec. 2011.
0166-0934
10.1016/j.jviromet.2010.12.010
1879-0984
Autor
Costa, Catia Inês
Delgado, Isabella Fernandes
Costa, Jaline Alves Cabral da
Carvalho, Renata Faria de
Mouta, Sérgio da Silva
Vianna, Carlos Otávio Alves
Moraes, Márcia Terezinha Baroni de
Resumen
Commercial enzyme-linked immunosorbent assay (ELISA) kits for the determination of the in vitro potency of recombinant hepatitis B vaccines, which detect hepatitis B surface antigen (HBsAg), have been used frequently as an alternative for traditional in vivo potency tests. With the constant need for validation procedures, an ELISA that could be employed to determine the in vitro potency of five recombinant hepatitis B vaccines simultaneously was established using two monoclonal antibodies. The use of two monoclonal antibodies produced "in house" specific for the small envelope protein S of the hepatitis B virus (HBV) resulted in the production of a highly specific, sensitive and stable ELISA. The standard ELISA parameters used in this study, considering the HBsAg content of each recombinant hepatitis B vaccine evaluated, resulted in a standard curve that could be applied for potency evaluations of different, commercial hepatitis B vaccine lots. 2030-01-01