CAJ | 학술논문

目的：建立孕妇外周血妊娠相关蛋白A的鲁米诺氧通道免疫测定方法。方法：采用1株鼠抗人PAPP-A单克隆抗体用于生物素标记，兔抗人PAPP-A多克隆抗体包被受体微球，与包被有链霉亲和素的供体微粒共同构成检测试剂，优化检测条件并评价检测性能。结果：本方法的批内及批间精密度为5.91％～7.94％和6.14％～9.69％；分析灵敏度2.8 mU／L，功能灵敏度4.6 mU／L，在2.8～8000 mU／L范围内线性良好；回收率为96.7％～100.3％，通过干扰性实验分析溶血、黄疸和脂血的干扰率均＜10％；当PAPP-A浓度高达8000 mU／L时，无Hook效应；本文所建立方法检测50份临床标本，结果与时间分辨荧光分析法的结果相关系数为0.989。结论：本研究建立的方法能够用于孕妇血清PAPP-A的定量测定，检测性能符合临床诊断试剂的要求。
목적：건립잉부외주혈임신상관단백A적로미낙양통도면역측정방법。방법：채용1주서항인PAPP-A단극륭항체용우생물소표기，토항인PAPP-A다극륭항체포피수체미구，여포피유련매친화소적공체미립공동구성검측시제，우화검측조건병평개검측성능。결과：본방법적비내급비간정밀도위5.91％～7.94％화6.14％～9.69％；분석령민도2.8 mU／L，공능령민도4.6 mU／L，재2.8～8000 mU／L범위내선성량호；회수솔위96.7％～100.3％，통과간우성실험분석용혈、황달화지혈적간우솔균＜10％；당PAPP-A농도고체8000 mU／L시，무Hook효응；본문소건립방법검측50빈림상표본，결과여시간분변형광분석법적결과상관계수위0.989。결론：본연구건립적방법능구용우잉부혈청PAPP-A적정량측정，검측성능부합림상진단시제적요구。
Objective:To develop a luminescent oxygen channeling immunoassay for pregnancy associated plasm a protein A.Methods:The monoclonal antibody of PAPP-A was labeled with biotin ,the polyclonal antibody of PAPP-A was coated on receptor particles.The LOCI reagents also contained sensitizer particles coated with streptavidin.The optimal test conditions and analytical per-formance of the method were studied.Results:The within-run and the between-run coefficients of variation were 5.91%-7.94% and 6.14%-9.69%,respectively;the analytical sensitivity was 2.8 mU/L and the function sensitivity was 4.6 mU/L,good linear in 2.8 mU/L-8 000 mU/L range;the recovery rate was 96.7%-100.3%.The interference rate of hemolysis , icterus and triglycerides were less than 10%; there is no Hook effect of PAPP-A concentrations up to 8 000 mU/L;the correlation coefficient between clinical samples detection results and Time resolved fluoroimmunoassay analysis results was 0.974.Conclusion:This LOCI can be used for the quantitative of serum PAPP-A,and detection performance in line with the requirements of clinical diagnostic reagents .