山西医科大学学报2025，Vol.56Issue(9)：1096-1100,5.DOI:10.13753/j.issn.1007-6611.2025.09.015
两种血清总胆红素参考测量方法检测结果的一致性评价
Consistency evaluation of results of two reference methods for total bilirubin in serum
摘要
Abstract
Objective To evaluate the comparability of the results of two reference measurement methods for total bilirubin in clinical serum samples,and provide data support for choosing reference measurement methods in laboratory test.Methods In accordance with the requirements of the CLSI EP9-A3 document,the Doumas total bilirubin reference method and the modified total bilirubin can-didate reference method of German Hannover Institute of Clinical Chemistry were selected for experiment of trueness,and then the re-maining serum of 40 patients were simultaneously detected by both the two methods.Outliers were detected by visual inspection.The trend of data variation was analyzed using deviation chart and percentage deviation chart.The bias of the test results of the two methods at the medical decision level was evaluated by Passing-Baklok regression model and Deming regression model.The results were evalu-ated based on the 1/2 TEa(7.5％)of the external quality assessment of the National Health Commission Clinical Laboratory Center as the acceptable standard.Results The mean values of the test results of the certified reference materials and RELA comparison samples by the two reference measurement methods were all within the qualified range,and the bias was less than±1.0％.There was a good correlation between the detection results by the two methods(R2=0.999),and no outliers were observed visually.The difference in the test results showed a mixed variation trend of constant and constant ratio.The Deming regression equation was y=0.976 3x-0.476 6,the 95％CI of the slope was 0.963 7-0.989 0,the 95％CI of the intercept was-1.370 5 to 0.417 3,and the correlation coeffi-cient R2=0.999.The Passing-Baklok regression equation was y=-0.096 8x+0.970 7,the 95％CI of the slope was 0.964 7-0.979 6,the 95％CI of the intercept was-0.506 6 to 0.252 4,and the correlation coefficient was R2=0.999.Based on two regression equations,the relative bias at the medical decision level was from-3.87％to-2.54％,which was less than 1/2 TEA(7.5％)of the inter-laboratory quality assessment of the National Health Commission Clinical Laboratory Center.Conclusion The consistency of the test results be-tween the candidate modified reference measurement method for total bilirubin and the classical reference measurement method meets the requirements of clinical testing.When the standard SRM916a can be stably obtained,the Doumas total bilirubin reference mea-surement method should be given priority.关键词
总胆红素/EP9-A3/参考测量方法/一致性/偏倚/允许总误差Key words
total bilirubin/EP9-A3/reference measurement procedure/agreement/bias/allowable total error分类
临床医学引用本文复制引用
孟祥兆,李敏,郭盈盈,李曾心,赵光轮,于洪远..两种血清总胆红素参考测量方法检测结果的一致性评价[J].山西医科大学学报,2025,56(9):1096-1100,5.基金项目
"国家质量基础的共性技术研究与应用"重点专项基金项目(2017YFF0205401) （2017YFF0205401）
