Method Verification for Determination of Diphtheria Antigen in Diphtheria Vaccine
Keywords:
Diphtheria antigen, Antigen content, Method verificationAbstract
This study was aimed to verify an Enzyme-linked Immunosorbent Assay (ELISA) used to determine an amount of diphtheria antigen (adsorbed antigen) and degree of adsorption in diphtheria vaccine. The results revealed that standard deviations (SD) and percentages of coefficient of variation (%CV) for adsorbed antigen and degree of adsorption in intra-assay precision were 1.01, 1.44 and 1.00, 0.29, respectively, while those of inter-assay precision were 1.01, 1.38 and 1.01, 0.59, respectively. For robustness analysis, values of SD and %CV for adsorbed antigen and degree of adsorption were 1.01, 1.19 and 1.01, 0.83, respectively, as determined by each analyst. In addition, no cross reaction to standard tetanus vaccine was shown, indicating that the method is specific to combined DTP vaccine. Our study could suggest that ELISA is appropriate to use as an alternative method to monitor consistency of diphtheria vaccine production.
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