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作 者:莫殿军[1]
机构地区:[1]赤峰学院附属医院检验科,内蒙古赤峰024000
出 处:《中国卫生检验杂志》2015年第6期842-843,共2页Chinese Journal of Health Laboratory Technology
摘 要:目的探讨血清催乳素在2种化学发光分析系统之间的检测结果是否具有可比性,并进行偏倚评估。方法参照美国的临床实验室标准化委员会(NCCLS)EP9-A2文件方案,每天选取8份临床血清样本,分别在罗氏E 602电化学发光免疫分析仪和西门子ADVIA CENTAUR XP化学发光分析仪上进行血清催乳素测定,连续5 d共40个样本,以罗氏E 602分析系统作为比较方法,西门子ADVIA CENTAUR XP分析系统作为实验方法,对两个系统测量的结果进行统计分析,做相关回归分析和偏倚评估。最后以我国卫生部临床检验中心血清催乳素室间质评的总允许误差的1/2为标准,判断两分析系统测定结果的可比性。结果催乳素在两分析系统间的检测结果线性良好,其回归方程为y=1.056 3x-18.459 2(r=0.997);血清催乳素浓度值在150μg/L和2 000μg/L 2个医学决定水平处的偏倚均在允许范围之内。结论血清催乳素检测在罗氏E 602与西门子ADVIA CENTAUR XP这两个不同检测系统间具有可比性,偏倚结果可以被接受。Objective To discuss whether the inspection results of the serum prolactin in two kinds of chemiluminescence analysis system are comparable,and to make bias evaluation to it. Methods According to document EP9- A2 of Clinical and Laboratory Standards Committee of the USA( NCCLS) program,8 clinical serum samples are chosen each day to be put into Roche E602 electrochemistry chemiluminescence immunoassay analyzer and Siemens ADVIA CENTAUR XP chemiluminescence analyzer to conduct serum prolactin test. 40 samples in 5 consecutive days are used to make statistic analysis as well as the correlation and regression analysis and bias evaluation of the two systems by the application of Roche E602 analysis system comparative method,and Siemens ADVIA CENTAUR XP analysis system as the experiment method. Finally taking total 1 /2 of allowable error issued by clinical laboratory center of the Ministry of Health of China in the EQA as the standard to judge the comparability of the results getting from the two analysis sytems. Results The linearity is good according to the prolactin test results in two analysis of subsystems,its regression equation was y = 1. 056 3x- 18. 459 2( r = 0. 997); the serum prolactin concentration values are at 150 μg / L and 2 000 μg / L which two medical decision bias level is within the allowable range. Conclusion The detection of serum prolactin is comparable between the E602 ADVIA CENTAUR XP Siemens Roche and the two different detection system,and the bias results can be accepted.
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