| Literature DB >> 21185330 |
Catia Inês Costa1, Isabella Fernandes Delgado, Jaline Alves Cabral da Costa, Renata Faria de Carvalho, Sérgio da Silva Mouta, Carlos Otávio Alves Vianna, Márcia Terezinha Baroni de Moraes.
Abstract
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.Entities:
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Year: 2010 PMID： 21185330 DOI： 10.1016/j.jviromet.2010.12.010
Source DB: PubMed Journal: J Virol Methods ISSN： 0166-0934 Impact factor: 2.014