第1代国家人源抗百日咳血清参考品的制备

Preparation of The First Generation of National Reference for Human Antiserum to Pertussis Antigen

目的制备第1代国家人源抗百日咳血清参考品。方法制备1批冻干候选人源抗百日咳血清参考品,以WHO第1代人源抗百日咳血清标准品(06/140)为标准,组织各单位进行协作标定,并对候选参考品进行稳定性分析。结果各协作实验室检测结果的室内和室间变异系数(CV)均低于15%;经统计学分析,最终确定候选参考品中含抗PT抗体94 IU/ml,抗FHA抗体52 IU/ml,抗Prn抗体106 IU/ml;候选参考品于-20℃放置15个月及37℃放置7、14、21和28 d后,各种百日咳抗体的酶标单位数均未出现显著下降。结论该候选参考品符合国家参考品的各项要求,可用于百日咳疫苗临床评价和临床实验室血清学诊断。

Objective To prepare the first generation of national reference for human antiserum to pertussis antigen.Methods One batch of candidate reference for human antiserum to pertussis antigen was prepared,calibrated cooperatively by several laboratories using WHO standard（06 / 140） for human antiserum to pertussis antigen as a standard,and evaluated for stability.Results Both the intra-and inter CVs of calibration results by various laboratories were less than 15%.The contents of anti-PT,anti-FHA and anti-Prn antibodies in the candidate reference were determined as 94,52 and 106 IU / ml respectively by statistical analysis.After storage at-20℃ for 15 months and at 37℃ for 7,14,21 and 28 d,no significant decreases were observed in the ELISA units of various pertussis antibodies.Conclusion The candidate reference met the requirements for national reference and might be used for the clinical evaluation of pertussis vaccine and serological diagnosis of pertussis in laboratory.