摘要
目的对自制的癌胚抗原定量测定试剂盒(化学发光免疫分析法)进行临床应用研究及临床性能评价。方法用自制试剂盒检测采集到的血清1 156例和101例血浆,以罗氏公司癌胚抗原定量测定试剂盒(电化学发光法)为对照试剂,雅培公司癌胚抗原测定试剂盒(化学发光微粒子免疫检测法)作为复核试剂,对自制试剂盒的一致性和相关性等指标进行计算分析。结果同罗氏试剂盒相比,自制试剂盒异常符合率达96.1%,正常符合率达97.8%,总符合率达97.3%,Kappa值达0.931(P<0.01)。从定量测定值分析,与罗氏试剂盒测值相比,自制试剂盒测值的线性回归方程为Y=0.091+1.009X,相关系数为0.987(P<0.01),相关性良好。结论本试剂盒检测性能满足临床应用的需要。
Objective To investigate the clinic research of the carcinoembryonic antigen （CEA） quantitative diagnostic kit by chemiluminescent immunoassay （CLIA） （CEA-CLIA）. Methods 1 156 cases of serum and 101 cases of plasma were detected with the self-made kit. Roche carcinoembryonic antigen quantitative determination kit （ECL） were used as control agents, and Abbott carcinoembryonic antigen determination kit （CMIA） were used as a reagent in review. Consistency and correlation were calculated. Results The positive accordant ratio, the negative accordant ratio,the Kappa value was 96.1%,97.8%, 0.931 （P〈0.01）, respectively. Compared to Roche＇s kit in the quantitative analysis, the linear regression equation of the reagent was Y=0.091＋1.009X.The correlation coefficient was 0.987 （P〈0.01）. And the correlation coefficient was satisfy. Conclusion CEA-CLIA was a valuable diagnostic kit for clinic application.
出处
《分子诊断与治疗杂志》
2015年第5期318-322,共5页
Journal of Molecular Diagnostics and Therapy
基金
国家高技术研究发展计划(863计划)(2011AA02A101)
关键词
癌胚抗原
临床研究
化学发光免疫分析法
Carcinoembryonic antigen （CEA）
Clinic research
Chemiluminescent Immunoassay （CLIA）
