Validation of an in vitro potency test for the Cuban hepatitis B vaccine

Cuban Hepatitis B vaccine is used for immunisation in our country and by other countries. There is a need to harmonise the quality control procedures, mainly the potency tests. Taking into account that the in vivo potency test is more expensive, variable and longer than the alternative methods and that the commercial kits are expensive, we designed an in-house method based on the principle of the previous neutralisation test (using Hepanostika anti-HbsAg kit). This is the same principle used by the Cuban Hepatitis B manufacturer for lot release. The aim of this paper was to validate our in vitro method, to replace the in vivo test in our laboratory. We evaluated validation parameters such as specificity, accuracy, and precision with outstanding results. We also correlated our method with the in vitro test performed by the Cuban manufacturer (r=0.96, p=0.0093) and the method performed by Venezuela using commercial kits (for direct determination of antigen) and we got very good results (r=0.998, p=0.0009). The correlation with the in vivo potency test (using Hepanostika anti-HbsAg kit) was also good (r=0.995, p=0.0008).