不同软件对吸附无细胞百白破联合疫苗效价检测结果统计的影响  

Comparative analysis of influence of different computing software on titer test results of DTaP vaccine

作　　者：魏国良 朱婧靓 沈雪 李晶晶 赵淑双 邵宏秋 张芸畅 修华谦 王梦舒 徐娜 石亮 马霄[4] WEI Guoliang;ZHU Jingliang;SHEN Xue;LI Jingjing;ZHAO Shushuang;SHAO Hongqiu;ZHANG Yunchang;XIU Huaqian;WANG Mengshu;XU Na;SHI Liang;MA Xiao(College of Life Sciences,Jilin Agricultural University,Changchun 130118,Jilin Province,China;不详)

机构地区：[1]吉林农业大学生命科学学院,吉林长春130118 [2]吉林省药品审核查验中心(吉林省疫苗检查中心),吉林长春130062 [3]长春百克生物科技股份公司,吉林长春130062 [4]中国食品药品检定研究院,北京102600

出　　处：《中国生物制品学杂志》2024年第7期811-816,共6页Chinese Journal of Biologicals

基　　金：吉林省科技发展计划(20230204059YY)。

摘　　要：目的评价3种软件对吸附无细胞百白破联合疫苗效价检测结果统计的影响,以期为日常检测中分析软件的选择提供依据。方法采用《中国药典》三部(2020版)中规定的方法检测吸附无细胞百白破联合疫苗百日咳、破伤风及白喉效价。应用PLA 3.0、Stati及依据《中国药典》三部(2020版)通则1431编制的Excel计算表3种软件对吸附无细胞百白破联合疫苗效价检测数据进行统计,并计算效价相对值;应用质反应平行线法确定上述数据的95%可信限区间,并计算相对偏差。结果3种软件统计吸附无细胞百白破联合疫苗百日咳效价相对值为99.16%~100.46%,95%置信区间相对偏差均<3%;破伤风效价相对值为99.67%~100.46%,95%置信区间相对偏差均<1%;白喉效价相对值为97.33%~100.03%,95%置信区间上限相对偏差均<0,但95%置信区间下限相对偏差较大。结论3种软件可相互替代,其中Stati及通则软件适合部分无审计追踪要求的工作场景,PLA 3.0软件适合生物制品企业的质量控制体系应用。Objective To evaluate the influence of three kinds of software on the statistical results of titer detection of diphtheria tetanus acellular pertussis(DTaP)vaccine,so as to provide a basis for the selection of analysis software in daily detection.Methods The titers of pertussis,tetanus and diphtheria of DTaP vaccine were detected by the method specified in Chinese Pharmacopoeia(volumeⅢ,2020 edition).PLA 3.0 software,Stati software and Excel calculation table compiled according to the General Rules 1431 Biological Verification Statistical Method(General Rules 1431)of Chinese Pharmacopoeia(volumeⅢ,2020 edition)were used for the data statistics of the titer detection of DTaP vaccine,and the relative titer value was calculated.The 95%confidence limit interval of the above data was determined by using the mass reaction parallel line method,and the relative deviation was calculated.Results The relative titers of pertussis of DTaP vaccine calculated by three kinds of software were 99.16%-100.46%,and the relative deviations of 95%confidence interval were all less than 3%.The relative titers of tetanus ranged from 99.67%to 100.46%,with all the relative deviations of 95%confidence interval of less than 1%.The relative titers of diphtheria ranged from 97.33%to 100.03%,the relative deviations of the upper bound of 95%confidence interval were all less than 0,but those of the lower bound were large.Conclusion The three kinds of software can replace each other,among which Stati software and General Rules 1431 software are more suitable for some work scenarios without audit trail requirements,while PLA 3.0 software is more suitable for the quality control system in biological products enterprises.

关 键 词：吸附无细胞百白破联合疫苗 效价 统计软件 

分 类 号：Q331[生物学—遗传学]