Validation of a new alternative for determining in vitro potency in vaccines containing Hepatitis B from two different manufacturers.
Facing the discontinuation of the Auszyme kit, an alternative is needed for determining the in vitro potency of Hepatitis B surface antigen in vaccines. An inhibition ELISA has already proven to be reliable, but not in vaccine combinations. We validated this method by the evaluation of monovalent and combined vaccines from two different manufacturers. All validation parameters fulfilled the defined acceptance criteria. There was some interference with Hepatitis B potency, mainly produced by the whole cell Pertussis component, but it was not significant. A significant correlation between the Auszyme kit and the in vivo method was observed. We demonstrated that our ELISA is suitable for evaluating HB antigen in vaccines and could be considered as a potential alternative to the Auszyme kit.
Cuervo
Mario Landys Chovel
ML
Finlay Institute, Direction of Quality Control, Avenida 27, No. 19805, CP 11600, La Lisa, Ciudad de la Habana, Cuba. mlandys@finlay.edu.cu
Sterling
Ana Lara
AL
Nicot
Ivette Abreu
IA
Rodríguez
Mabel García
MG
García
Orlando Rodríguez
OR
D000818:Animals; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D006509:Hepatitis B / Q000276:immunology; D006510:Hepatitis B Antibodies / Q000737:chemistry*; D006514:Hepatitis B Surface Antigens / Q000737:chemistry*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D051379:Mice; D008807:Mice, Inbred BALB C; D015203:Reproducibility of Results; D012107:Research Design; D012680:Sensitivity and Specificity; D014765:Viral Vaccines / Q000737:chemistry; D014773:Virology / Q000379:methods / Q000639:trends
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D014765:Viral Vaccines