Performanceverification of ELISA kit for detecting residual bovine serum proteins in viral vaccines

To validate the reliability of BSP-ELISA kit for detecting residual bovine serum proteins in virus vaccines.Performanceverification of BSP-ELISA kit was carried on by six personnel from three departments,The outcome demonstrated that all eighteen tests done by six personnel had met tenable condition of standard curve of BSP-ELISA kit and the missionsuccess rate of building tenable standard curve is 100%.The precision was preferable because the coefficients of variation of the results among personnel detecting the BSP standards of 3,4,5,10,20ng/ml concentrations were from 1.96% to 6.24%,and the recovery from 94.8% to 98.7% indicated measuring results by various personnel had return accuracy.The detection quanta was as low as 3ng/ml.Furthermore,There is no cross reaction observed when detecting human serumalbumin,ovalbumin and vaccine protectins.the recovery is 90.0%and 117.1% when measuring BSA and B-IgG with BSP-ELISA kit respectively,The detection accord rate of residual bovine serum proteins between BSP-ELISA kit and BSA-ELISA kit in total 108 batches of eleven kinds of vaccines is 96.3%.The residual contents of bovine serum proteins is from 1.12 to 3.13 times as many as those of BSA in vaccines.BSP-ELISA kit can detect not only BSA but also other bovine serum proteins such as bovine IgG in vaccines sensitively but BSA-ELISA kit only can detect BSA,Which is most applicable on detecting residual bovine serum allergens in virus vaccines than the latterbecause BSA and bovine IgG are both primary residual allergen in vaccines.The kit would be useful for strict data quality monitoring of residual bovine serum in vaccines of our company.