不同发光检测系统总前列腺抗原测定结果的对比研究

目的探讨不同检测系统测定总前列腺抗原(TPSA)结果的可比性。方法取百乐、德普不同水平的质控物以及38份不同浓度的患者新鲜血清,在4个不同的化学发光免疫检测系统上进行TPSA检测,并对结果进行统计分析。结果经配伍组设计资料的方差分析,不同厂家、不同水平的质控物和不同浓度的患者新鲜血清TPSA测定结果在各检测系统的组间差异均有统计学意义(P0.01);各检测系统TPSA测定结果的信度系数a接近1;各检测系统问的相关系数均大于0.980。以雅培AXSYM系统作为目标检测系统,对其他检测系统作临床可接受性能评价,罗氏2010、贝克曼Access、德普Immulite-1000检测系统临床均可接受。结论 4个检测系统测定TPSA结果的精密度符合临床要求,临床可接受性能评价具有可比性。

Research on the comparability of total prostate specific antigen result measured with different kinds of assay system

Objective To study the comparability of total prostate specific antigen(TPSA)results obtained with different detection system.Methods 4 kinds of chemiluminescence immunoassay system(ABBOTT AXSYM,Roche2010.Beckmancoulter Access and DPC immulite-1000)were used to detect TPSA concentration in 2 kinds of quality control specimen(Bayer and DPC)and 38 patient samples of different concentration.The results were analyzed with statistics methods.Results Analysis of variance showed that TPSA results from different controls an d patient samples had significant difference in different assay system(P<0.01).The correlation coefficient of each detection system was above 0.980 and the reliability coefficient of them was closed to 1.When Johnson VITROS ECI Was regarded as a target detection system in order to evaluate the acceptability of other detection system,all detection systems in our study could be accepted by clinic assessment.Conclusion The precision of TPSA results in the 4 kinds of detection system accord to clinical requirement.Comparability exists in the evaluation of clinical acceptability.