国产Auto TRFIA-4型自动荧光免疫分析仪与试剂盒检测妊娠相关血浆蛋白A的性能评价与参考区间的建立

Performance Evaluation of Domestic Auto TRFIA-4 Model Automatic Fluorescence Immunoassay and Kit for Detection of Pregnancy Associatied Plasma Protein A and Establishment of Reference Interval

目的评价国产Auto TRFIA-4型自动荧光免疫分析仪与试剂盒检测妊娠相关血浆蛋白A(PAPP-A)的性能,并建立参考区间。方法国产Auto TRFIA-4型自动荧光免疫分析仪与试剂盒组成待评价系统。依据PAPP-A检测试剂盒医药行业标准,对待评价系统检测PAPP-A的检测限、线性和精密度进行评价;并采用方法学比对试验检测了66例孕早期不同孕周的孕母血清样本,进行准确度评价。参考C28-A2文件,待评价系统检测了2524例孕早期不同孕周的孕母血清样本,进行PAPP-A参考区间的建立。结果待评价系统检测PAPP-A的空白限为0.50 mIU/L,检测限优于25.00 mIU/L,线性在9.00~2530.00 mIU/L内的相关系数(r)达0.9998,批内变异系数(CV)小于3%,批间CV小于4%。待评价系统与对比系统检测血清样本结果的线性回归方程为Y=0.9373X+271.15,r=0.9966(tr=96.68,P﹤0.05),且两系统检测的PAPP-A浓度结果差异无统计学意义(t=1.10,P﹥0.05)。在9~9+6,10~10+6,11~11+6,12~12+6和13~13+6孕周的PAPP-A中位数分别为977,1550,2536,3683和5393 mIU/L。结论待评价系统检测PAPP-A满足PAPP-A检测试剂盒医药行业标准的要求,建立的PAPP-A参考区间以供临床参考。

Objective To evaluate the performance of a domestic Auto TRFIA-4 model automatic fluorescence immunoassay analyzer and kit for detecting pregnancy associatied plasma protein A(PAPP-A)and establish it's reference interval.Methods The evaluation system was constited of the domestic Auto TRFIA-4 model automatic fluorescence immunoassay analyzer and kit.The detection limit,linearity and precision of the evaluation system for detecting PAPP-A were evaluated,which accorded to the pharmaceutical industry standard of PAPP-A detection reagent kit.The accuracy was evaluated by testing 66 cases of maternal serum samples from different gestational weeks in the first trimester,which based on methodological comparison test method.The reference interval of the evaluation system was established by detecting 2524 pregnant women's serum samples from different gestational weeks in the first trimester,which referenced to C28-A2 file.Results The blank limit of the evaluation system for detecting PAPP-A was 0.50 mIU/L,the detection limit was better than 25.00 mIU/L,the correlation coefficient(r)was reached 0.9998 within the linear range of 9.00 to 2530.00 mIU/L,the coefficient of variation(CV)of inter-assay was less than 3%,and the CV of intra-assay was less than 4%.The linear regression equation of the clinical serum sample results of the evaluation system and the comparison system was Y=0.9373X+271.15,r=0.9966(tr=96.68,P<0.05).There was no significant difference in PAPP-A concentration between the two systems(t=1.10,P>0.05).The PAPP-A median was 977,1550,2536,3683 and 5393 mIU/L at 9~9+6,10~10+6,11~11+6,12~12+6 and 13~13+6 gestational week,respectively.Conclusion The performance of the evaluation system for detecting PAPP-A met the requirements of the pharmaceutical industry standard of PAPP-A detection reagent kit,and the PAPP-A reference interval was established for clinical reference.