单向免疫扩散测定四价流感病毒裂解疫苗中两种B型血凝素含量

摘要

目的 四价流感病毒裂解疫苗在三价疫苗中新增一个谱系的B型血凝素抗原,单向免疫扩散法(single radial immunodiffusion,SRID)是否能准确测定四价疫苗中两种谱系的B型血凝素抗原含量.方法 采用江苏金迪克生物技术有限公司研制的四价流感病毒裂解疫苗,运用SRID进行测定.结果 在正常检测范围内(10～40μg/ml)比较标准品抗原对照、单价样品、B1+B2单价样品的血凝素测定值差异无统计学意义(P>0.05).在10～160μg/ml检测范围内分别以三价苗和固定浓度30μg/ml的B型血凝素为基质稀释待测的另一B型血凝素,与该B型不同稀释度的单一血凝素测定结果进行比较,以测定两种B型流感血凝素有无互相干扰.在流感疫苗血凝素检测范围10～40μg/ml之内时,检测的血凝素含量与沉淀环直径呈正比关系(决定系数R2=0.998),而在10～160μg/ml检测范围内,三元线性回归方程拟合度最高(决定系数R2=0.999).结论 单向免疫扩散法检测B1和B2毒株的血凝素抗原在10～40μg/ml和10～160μg/ml范围内和存在其他三种血凝素或另一B型血凝素时,均未见互相干扰.%Objective Quadrivalent influenza vaccines contain two lineages of type B virus, this study aimed to assess whether the result of single radial immunodiffusion (SRID) are accurate. The cross-interference of two type B hemagglutinins remains unknown. Methods We detected the vaccine samples developed by Jiangsu GDK Biological Technology Co. , ltd by SRID. Results There was no significant difference between the HA content of antigen reagent, bulk sample and mixed sample of two B bulk within 10 to 40 μg/ ml (P > 0. 05). Then each hemagglutinin B was diluted respectively by other three HA, 30 μg/ml, the other hemagglutinin B or phosphate buffer solution were measured within 10-160 μg/ ml. Within 10-40 μg/ ml, the HA content was proportional to the diameters of immunodiffusion (R2 = 0. 998), while within the higher content range, a ternary linear regression equation fitted best (R2 = 0. 999). Conclusions No cross-interference between B/ Brisbane and B/ Phuket was found in SRID within both detection ranges.