两种血清总胆红素临床检测方法的偏倚分析和一致性评价

Bias analysis and consistency evaluation of two methods for clinical detection of serum total bilirubin

目的 依据美国临床实验室标准化协会(CLSI)发布的EP9-A3文件评价两套血清总胆红素检测系统检测结果的一致性。方法 收集2021年12月北京航天总医院门急诊及住院病人血清40例,以由迈克氧化法试剂及雅培C16000生化分析仪组成的常规检测系统作为参比系统,以西门子Dimension EXL 200及其配套试剂组成的检测系统为待评系统,对检测结果进行分析,选取Passing-Baklok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 TEa(7.5%)为可接受标准。结果 使用Passing-Baklok回归对结果进行线性拟合,回归方程为Y=1.001X+1.821,将医学决定水平处的值34.2、171、342分别带入回归方程,计算得到的相对偏移分别为5.3%、1.2%和0.6%,小于国家卫健委临床检验中心室间质评1/2 TEa(7.5%),满足要求。结论 该实验室使用的两种血清总胆红素检测方法结果具有可比性。

Objective To evaluate the consistency of two methods for the detection of serum total bilirubin according to the EP9-A3document published by the American Clinical Laboratory Standardization Association(CLSI).Methods The serum samples of 40 patients from outpatient emergency and inpatient patients of Beijing Aerospace General Hospital were collected,The conventional detection system composed of Mike's oxidation reagent and Abbott C16000 biochemical analyzer was used as the reference system,and the detection system composed of Siemens Dimension EXL 200 and its supporting reagents were used as the evaluation system.The detection results were analyzed,and the Passing Baklok regression model was selected to fit the regression equation.The deviation at the medical decision level was calculated,and the acceptable standard was 1/2 TEa(7.5%) of the laboratory quality assessment of the Clinical Laboratory Center of the National Health Commission.Results The results were linearly fitted with Passing Baklok regression,the regression equation was Y=1.001X+1.821.The values of 34.2,171 and 342 at the medical determination level were inserted into the regression equation,and the calculated relative offsets were 5.3%,1.2% and 0.6%,respectively.which were less than 1/2 TEa(7.5%) of the laboratory quality assessment of the Clinical Laboratory Center of the National Health Commission,meeting the requirements.Conclusion The1 0r0esults of two methods for detecting total bilirubin in serum used in our laboratory are comparable.