两种不同检测系统测定血清总蛋白的结果比对与偏倚评估

Results comparison and bias estimation between two different biochemical detection systems for serum total protein assays

目的探讨本实验室内待测系统与参比系统测定血清总蛋白(TP)的可比性。方法参照临床和实验室标准化协会(CLSI)颁发的EP9-A2文件,每天取患者样本8份,分别用待测系统与参比系统测定TP,并且每次均进行平行管测定,共测定5天;记录试验数据,经离群点检验后,计算相关系数和回归方程,进行偏倚评估。结果测定结果无方法内离群点及方法间离群点;两种检测系统TP测定结果的相关系数和回归方程分别为r=0.999(P=0.000),Y=1.035X-1.211(X、Y分别为参比系统、待测系统的TP测定结果);两种检测系统在TP医学决定水平(Xc)处的预期偏倚(Bc)小于可接受偏倚(P<0.05)。结论上述两种检测系统测定血清TP的结果基本一致,在本实验室内可以使用两种系统检测血清TP。

Objective To investigate the comparability of serum total protein （TP） test results between our detection system and the reference system. Methods According to the EP9-A2 document described by the Clinical and Laboratory Standards Institute （CLSI）, 40 patient samples were analyzed in 5 days, and each pa- tient sample was analyzed in duplicate using both our detection system and the reference system. After the out-lier tests, the correlation coefficient, regression equation and bias between the two detection systems Were cal-culated. Results There were no within-method outlier or between-method outlier in the experimental data. The correlation coefficient and the regression equation for serum TP between two detection systems were 0.999 （P=0.000）and Y=1.035X-1.211, respectively. The predicted bias at each given medical decision level was less than the acceptable bias （P〈0.05）. Conclusion The serum TP test values from our detection system agree with the results of reference system, and each of them can be used to measure serum TP in our laboratory.