罗式电化学发光法在乙型肝炎疫苗质量控制中的应用

目的用罗式电化学发光法检测乙型肝炎疫苗(酵母)生产过程中纯化工序关键样品的HBsAg含量和疫苗的体外相对效力(RP),以取代雅培珠式EIA法。方法分别用科华板式EIA法、雅培MUREX板式EIA法、罗式电化学发光法与雅培珠式EIA法对比检测重组乙型肝炎疫苗(酵母)生产过程中纯化工序关键样品的HBsAg含量和疫苗的RP值,并分析3种方法的精密性。结果科华板式EIA法和雅培MUREX板式EIA法检测纯化工序关键样品的HBsAg含量结果与雅培珠式EIA法比较,差异均有统计学意义,且精密性均不佳;罗式电化学发光法检测纯化工序关键样品的HBsAg含量及疫苗的RP值结果与雅培珠式EIA法比较,差异均无统计学意义,且精密性均良好。结论罗式电化学发光法可以替代雅培珠式EIA法,检测乙肝疫苗(酵母)生产过程中HBsAg含量和疫苗的RP值。

Application of Roche Electrical Chemiluminescence Immunoassay to Quality Control of Hepatitis B Vaccine

Objective To determine the HBsAg content and relative potency(RP)in vitro of key samples at purification step of production procedure of hepatitis B(HB)vaccine(yeas)tby Roche electrical chemiluminescence immunoassay(ECI)and investigate the feasibility of substitution of bead EIA with ECI.Methods The HBsAg content and RP of key samples at purification step of production of recombinant HB vaccine(yeas)twere determined by Kehua Plate EIA(Kehuan EIA),Abbott MUREX Plate EIA (MUREX EIA)and ECI,and the results were compared with that by Abbott Bead EIA(Bead EIA),based on which the precisions of the three methods were analyzed.Results The determination result of HBsAg content by Kehua EIA showed significant difference with that by Bead EIA,and both the precisions of the two methods were relatively low.However,ECI showed high precision,by which the determination results of HBsAg and RP showed no significant difference with that by Bead EIA.Conclusion ECI may be used for determination of HBsAg content and RP of recombinant HB vaccine(yeas)tduring production in stead of Bead EIA.