时间分辨免疫荧光法定量检测癌胚抗原(CEA)试剂临床应用研究

目的对自制时间分辨免疫荧光法定量检测癌胚抗原(CEA)试剂盒进行临床应用研究,为该试剂盒临床应用及临床疗效评价提供科学依据。方法收集血清标本326份,用自制试剂盒按试剂盒操作说明书对血样进行测定,并以化学发光法(R oche)为对照方法,W ALLAC公司的CEA时间分辨免疫测定药盒(A u toDELF IATMhCEA)作为复核试验,获取相关目标实验数据,并计算得“真实性”和“可靠性”等统计学数据。结果以化学发光法为对照试验,其阳性符合率为95.83%,阴性符合率为98.73%,检验无显著性差异;自制试剂盒的定量测定值与化学发光法的测定值较为一致,相关系数达0.93,相关性好。结论试剂盒检测性能与现在临床广泛应用的方法相仿,能满足临床应用的需要。

The Clinic Study of the Carcinoembryonic Antigen (CEA) Quantitative Diagnostic Kit with TRFIA

Objective Using the technique of timed-resolved fluoroimmunoassay(TRFIA),carcinoembryonic antigen(CEA) quantitative diagnostic kit has been successfully developed.And the capability of the kit has been evaluated.Methods In this study,the clinic evaluation has been undertaken.In research 326 blood samples were collected for CEA detecting analysis.Results Comparing to the technique of chemiluminescence immunoassay(CLIA),the positive accordant ratio of diagnostic kit was 95.83%,while the negative accordant ratio was 98.73%.Meanwhile,the relativity of diagnostic kit with CLIA was well,and the relative coefficient was 0.93.Conclusion All the results of the parameters evaluated showed that the diagnostic kit developed could meet the need of the clinic application.