SUMMARY:The parallel line assay method was applied on the potency test of HB vaccine in guinea pigs. The applicability of the method was investigated to obtain information on the possible effect of inactivation process of HBs antigen, on the magnitude of adjuvant effect of aluminum compound and so on. The precision of the method was found to be comparable to those of diphtheria and tetanus toxoids.
SUMMARY: Precise and reproducible quantitative determination of hepatitis B surface antigen by applying the parallel line bioassay method was proposed . In this method, the value of any given sample can be expressed in terms of a relative value to a fixed standard or reference preparation.Decrease in antigenic reactivity due to the lowered protein content could be pre vented by using 0.02% human albumin in physiological saline solution as the diluent . Th e use of such stabilizer(s) should be considered in the dilution or storage of samples containing HBs antigen.
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