论文部分内容阅读
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 human anti-pertussis serum reference. Methods A batch of freeze-dried candidate human anti-pertussis serum reference material was prepared. The WHO 1st generation human anti-pertussis serum standard (06/140) was used as a standard, and each unit of the tissue was calibrated in collaboration and stability of the candidate reference material analysis. Results The indoor and laboratory CVs of all the cooperative laboratories were less than 15%. After statistical analysis, 94 IU / ml of anti-PT antibody, 52 IU / ml of anti-FHA antibody, Anti-Prn antibody 106 IU / ml; candidate reference samples were placed at -20 ℃ for 15 months and 37 ℃ for 7,14,21 and 28 d after the various pertussis antibodies did not significantly reduce the number of units. Conclusion This reference candidate conforms to the national reference requirements and can be used in clinical evaluation and clinical laboratory serological diagnosis of pertussis vaccine.