两种化学发光系统检测甲胎蛋白的可比性研究

摘要

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.%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20 ng/mL、400 ng/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.