Establishment and validation of an ELISA for the quantitation of HBsAg in recombinant hepatitis B vaccines

被引：23

作者：

Costa, Catia Ines ^{[3
,4
]}

Delgado, Isabella Fernandes ^{[3
,4
]}

Cabral da Costa, Jaline Alves ^{[3
]}

de Carvalho, Renata Faria ^{[3
]}

Mouta e Junior, Sergio da Silva ^{[1
]}

Alves Vianna, Carlos Otavio ^{[2
]}

Baroni de Moraes, Marcia Terezinha ^{[1
,2
]}

机构：

[1] Oswaldo Cruz Fdn FIOCRUZ, Mol Virol Lab, Inst Oswaldo Cruz, BR-926 Rio De Janeiro, Brazil

[2] Oswaldo Cruz Fdn FIOCRUZ, Lab Recombinant Technol, BR-926 Rio De Janeiro, Brazil

[3] Oswaldo Cruz Fdn FIOCRUZ, Natl Inst Qual Control Hlth INCQs, Dept Immunol, BR-926 Rio De Janeiro, Brazil

[4] Oswaldo Cruz Fdn FIOCRUZ, Natl Inst Qual Control Hlth INCQs, Post Grad Program Hlth Surveillance, BR-926 Rio De Janeiro, Brazil

来源：

JOURNAL OF VIROLOGICAL METHODS | 2011年 / 172卷 / 1-2期

关键词：

Hepatitis B virus; Hepatitis B surface antigen; Monoclonal antibody; ELISA; Potency test; COMPREHENSIVE IMMUNIZATION STRATEGY; ELIMINATE TRANSMISSION; ADVISORY-COMMITTEE; VIRUS INFECTION; UNITED-STATES; RECOMMENDATIONS;

D O I：

10.1016/j.jviromet.2010.12.010

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

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. (C) 2011 Elsevier B.V. All rights reserved.

引用

页码：32 / 37

页数：6

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