基于CLSI EP9-A3的总胆红素方法学比对及偏移评估

A Study of Methodological Comparison and Bias Evaluationof Total Bilirubin Based on CLSI EP9-A3

目的应用美国临床和实验室标准化协会(CLSI)EP9-A3文件评价两种方法学检测血清总胆红素结果的可比性,评估常规检测系统能否满足临床需求。方法收集北京航天总医院患者新鲜血清标本40例,以总胆红素Doumas参考方法作为参比系统,迈克氧化法试剂及雅培C16000生化分析仪组成的检测系统作为待评系统,对检测结果进行分析,选取最适合的回归模型拟合回归方程,计算其在医学决定水平处的偏移,以国家卫健委临床检验中心室间质评1/2允许总误差TEa(7.5%)为可接受标准。结果待评系统与参比系统的检测结果分别为56.27(32.90,125.33)μmol/L、63.05(36.09,139.16)μmol/L,差异有统计学意义(Z=-5.511,P<0.05)。选择Deming和Passing-Baklok回归对结果进行线性拟合,回归方程分别为Y=0.958 X-2.756(r=0.998)和Y=0.942 X-1.453(r=0.999)。将医学决定水平值34.2、171、342分别代入回归方程,计算得到的相对偏移分别为-13.06%、-5.99%、-5.13%和-10.58%、-6.88%、-6.42%。结论待评的常规检测系统与参比系统间存在明显负偏移,低值医学决定水平处的偏移不可接受。

Objective To evaluate the comparability of serum total bilirubin detection results between two methods using the EP9-A3 document of the American Institute for Clinical and Laboratory Standardization(CLSI)and to evaluate whether the routine detection system can meet the clinical needs.Methods 40 fresh serum samples from patients in Beijing Aerospace General Hospital were collected for the study.The total bilirubin Doumas reference method was used as the reference system,while the detection system composed of Mike oxidation reagents and Abbott C16000 biochemical analyzer was used as the system to be evaluated.The detection results were then analyzed.We selected the most suitable regression model to fit the regression equation,calculated its offset at the medical decision level and took the 1/2 allowable total error TEa(7.5%)of the National Health Commission Clinical Laboratory Center as the acceptable standard.Results The test results of the system to be evaluated and the reference system were 56.27(32.90,125.33)μmol/L,63.05(36.09,139.16)μmol/L and the difference was statistically significant(Z=-5.511,P<0.05).Deming and Passing-Baklok regression were selected to perform the linear fitting on the results and the regression equations were Y=0.958 X-2.756(r=0.998)and Y=0.942 X-1.453(r=0.999),respectively.We substituted the medical decision level values 34.2,171 and 342 into the regression equation respectively and the calculated relative offsets,which were-13.06%,-5.99%,-5.13%and-10.58%,-6.88%and-6.42%,respectively.Conclusion There is a significant negative offset between the routine detection system to be evaluated and the reference system and the offset at the low medical decision level is unacceptable.