牛血清蛋白酶联免疫试剂盒性能的验证

为了全面验证研制的牛血清蛋白(BSP)酶联免疫试剂盒的性能,由3个部门6人协作进行了验证。结果表明,,6人进行的18次试验全部满足BSP-ELISA试剂盒的质控标准,达标率100%;6名实验人员对3、4、5、10、20ng/ml浓度的BSP标准品进行测定,结果变异系数在1.96%~6.24%之间,精密度较好;回收率在94.8%~98.7%之间,准确度理想,测量限量为3ng/ml。该试剂盒与人血白蛋白、卵清蛋白等均无交叉反应,对BSA、B-IgG特异性蛋白的检测回收率为101.2%和94.7%;与牛血清白蛋白试剂盒对比测定11种疫苗总计108批,符合率为96.3%,针对不同疫苗,BSP残余量约为BSA的1.12~3.13倍,验证结果表明,该试剂盒可检测疫苗中BSP而不仅是BSA,能更全面客观地反映疫苗中牛血清的真实情况,有利于疫苗生产的严格质量监控。

Performance verification 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.