两种化学发光系统检测甲胎蛋白的可比性研究

目的探讨州泰ZT-480型化学发光分析系统与贝克曼Access2型化学发光分析系统检测血清甲胎蛋白(AFP)的可比性及临床可接受性。方法收集120份新鲜血清标本,其AFP浓度范围覆盖AFP的可报告范围,分别在州泰ZT-480型及贝克曼Access2型化学发光分析仪上同时检测。以贝克曼Access2型化学发光分析仪为比较系统,对采用州泰ZT-480型化学发光分析系统检测的结果进行相关性分析,偏差分析,评估阴、阳性符合率。结果 AFP检测结果在两系统间的差异具有统计学意义(P<0.01),相关系数为0.977 3,在20ng/mL、400ng/mL处,相对偏差分别为24.1%、7.9%,两系统的阳性符合率、阴性符合率、总符合率分别为100.0%、95.4%、96.7%。结论两系统的临床可接受性能具有可比性,州泰ZT-480型化学发光分析系统可用于AFP的临床检测。

A comparability study of two chemiluminescent measurement systems in detection of alpha-fetal protein

Objective To explore the comparability and clinical acceptability of serum alpha-fetal protein(AFP) detection using Taizhou ZT-480 chemiluminescent immunoassay system and Beckman Access 2 chemiluminescent immunoassay system.Methods 120 fresh serum samples with concentration range of AFP covering the scope of reportable concentration were collected,and were detected using Taizhou ZT-480 and Beckman Access 2 chemiluminescent immunoassay systems simultaneously and respectively.Beckman Access 2 chemiluminescent immunoassay system served as comparison system,results obtained from Taizhou ZT-480 chemiluminescent immunoassay system were subjected to analysis of correlation and variance and evaluation of negative and positive coincidence rate.Results Difference of AFP between the two systems showed statistical significance(P<0.01) with correlation coefficient of 0.977 3.The relative deviation were 24.1%,7.9% at the concentrations of 20 ng/mL,400 ng/mL,respectively.The positive coincidence rate,negative coincidence rate and total coincidence rate of the two system were 100.0%,95.4%,96.7%,respectively.Conclusion Clinical acceptable performance of the two system is comparable,and Taizhou ZT-480 chemiluminescent immunoassay system can be utilized for the clinical AFP detection.