不同检测系统孕酮测定结果的可比性研究

Comparability Research on Progesterone Results among Different Kinds of Detection System

目的探讨不同检测系统测定孕酮(PRGE)结果的可比性.方法取Bayer、德普和自制不同水平的质控物,以及35例不同浓度的患者新鲜血清,在四个不同的化学发光检测系统(强生VITROS ECI、拜尔ACS180、拜尔CENTAUR、德普immulite-1000及其配套的校准物、试剂、质控物等,分别命名为检测系统1～4)上进行PRGE检测,并对数据进行相关的统计学分析.结果经随机区组设计资料的方差分析,不同水平的质控物和不同浓度的患者新鲜血清PRGE测定结果在各检测系统的组间总体差异均有显著性(P＜0.001);各检测系统PRGE测定结果的可靠性系数a接近1,各检洲系统间的相关系数均大于0.975.以检测系统1作为目标检测系统,对其它检测系统作临床可接受性能评价,检测系统2和3临床均接受,检测系统4临床部分接受.结论4个检测系统测定PRGE结果的精密度符合临床要求,临床可接受性能评价除检测系统4外均有可比性.

Objective To discuss the comparability of progesterone （PRGE） results among different detection systems. Methods 4 different kinds of chemiluminescence immune detection system （VITROS ECI,Bayer ACS180,Bayer CENTAUR and DPC immulite-1000 were named detection system 1～4,respectively） were used to detect PRGE concentration in 3 kinds of quality controls （Bayer,DPC and self-made） and 35 clinical sera. The collected data were dealt with statistics analysis. Results Analysis of variance showed the PRGE results from different control and patients sera had significant difference in different detection systems （P〈0. 001）. The correlation coefficient of each detection system was above 0. 975 and the reliability coefficient of them were close to 1. Regarded detection system 1 as target detection system and evaluated the acceptability of other detection systems. As a result,detection system 2 and 3 were accepted and detection system 4 was partly accepted by clinic assessment. Conclusion The precision of PRGE results in the 4 kinds of detection systems accorded to clinic requirement. Comparability existed in the evaluation of clinical acceptability except detection system 4.