【摘要】 目的探讨德国生产Lumino半自动化学发光免疫分析仪和国产全自动MAGLUMI2000化学发光免疫分析仪对糖类抗原50(CA50)的检测结果是否具有可比性。方法按照美国临床实验室标准化委员会(NCCLS)EP9-A文件要求,以德国生产半自动化学发光免疫分析仪为比较仪器,国产全自动MAGLUMI2000化学发光免疫分析仪为实验仪器,每天随机从临床样本中抽取8份不同浓度的血清样本,分别用两种不同检测系统进行CA50的测定,共测定5 d,记录检测结果,并对结果数据之间相关性及相对偏差进行评估。结果两种检测系统CA50的配对t检验显示,两组间结果差异无统计学意义。同时两系统的检测结果具有较好的相关性,相关系数r=0.9784,直线回归方程为y=1.0266x+0.9432,在25 IU/ml和100 IU/ml水平的相对偏差分别为6.37%和3.54%。结论两种检测系统的结果具有一致性,检验结果可以被临床接受。更多还原

【Abstract】 Objective To explore the comparability and bias estimation for the detection result of CA50 between the Lumino semi-automatic chemiluminescent immunoassay analyzer(Germany) and the MAGLUMI2000 full-automatic chemiluminescent immunoassay analyzer(China). Methods According to the requirement of the NCCLS EP9-A, the Lumino was used as the comparative instrument, while the MAGLUMI 2000 was used as the experimental instrument. 8 patient samples with different serum CA50 were analyzed each day, respectively, with two analytic systems for 5 consecutive days and then the bias estimation of the two analytic systems were evaluated. Results There was no significant difference between the two detecting systems for CA50 by the method of paired t tests. The two detecting systems were highly correlated with the coefficient r=0.9784. The linear regression equation was y=1.0266x+0.9432, and the relative deviation at 25 IU/m L and 100 IU/m L were 6.37% and 3.54%, respectively.Conclusion The detecting results of the two systems are consistent and acceptable in the clinical application.更多还原