4种检测系统测定血清胆红素的差异性研究  

A Differential Analysis of Four Detection Systems for Bilirubin Detection

作　　者：张鲍虎 张玲玲 郑耿镇 张莉[1] 杨书才 周杰[1] ZHANG Baohu;ZHANG Lingling;ZHENG Gengzhen;ZHANG Li;YANG Shucai;ZHOU Jie(Pingshan General Hospital of Southern Medical University,Shenzhen Pingshan District People’s Hospital,Shenzhen 510800,China)

机构地区：[1]南方医科大学坪山总医院深圳市坪山区人民医院,广东深圳510800

出　　处：《标记免疫分析与临床》2023年第3期517-522,共6页Labeled Immunoassays and Clinical Medicine

基　　金：深圳市坪山区医疗健康集团(南方医科大学坪山总医院)2022年度院长基金资助科研项目(编号:202211)。

摘　　要：目的使用重氮法和钒酸盐氧化法共4个检测系统测定血清中总胆红素(TBIL)和直接胆红素(DBIL)的含量,评估不同方法间及同一方法不同检测系统间TBIL和DBIL的检测结果,为判断临床检验科室不同检测系统之间的结果能否互认提供试验依据。方法以罗氏、贝克曼作为重氮法检测系统,日本和光、新产业作为钒酸盐氧化法检测系统,使用临床检验剩余样本进行检测。对检测值分析,计算不同系统间的相关系数r,建立Passing-Bablok回归模型。使用Bland-Altman一致性分析及一致性相关系数(CCC)评估不同检测系统检测结果的一致性。计算各检测系统在DBIL和TBIL医学决定水平处的相对偏差,以1/4TEa为标准,评估试剂间的偏倚情况。结果共纳入181例样本进行研究。钒酸盐氧化法检测DBIL和TBIL的试剂间相关系数均大于0.975,相比重氮法相关性更好,Passing-Bablok回归分析提示钒酸盐氧化法试剂间的比例及系统偏倚更小。一致性分析表明钒酸盐氧化法试剂间比对一致性较好,CCC均大于0.99。在不同医学决定水平处,钒酸盐氧化法试剂DBIL及TBIL检测结果均符合1/4TEa标准,而在6.8μmol/L水平处,重氮法试剂DBIL的结果在1/4TEa标准的可接受范围之外。结论钒酸盐氧化法试剂间检测结果一致性较好,且TBIL试剂一致性优于DBIL。重氮法和钒酸盐氧化法不同检测原理试剂间测定结果的可比性较差。Objective A total of four detection systems were used to determine the content of total bilirubin(TBIL)and direct bilirubin(DBIL)in serum by diazo method and vanadate oxidation method,and the detection results of TBIL and DBIL between different methods and different detection systems of the same method were evaluated to provide experimental evidences for inter-accreditation among different detection systems in clinical laboratories.Methods Roche and Beckman were used as diazo detection systems,while Wako and Snibe reagents were served as vanadate oxidation systems and the clinical residual samples were used for the detection.The detection results were then analyzed.The correlation coefficient,Passing-Bablok regression model,Bland-Altman analysis and Consistency Correlation Coefficient(CCC)analysis were used to evaluate the correlation and consistency of different methods.The relative deviation at medical decision levels of TBIL and DBIL were analyzed to evaluate the bias among different reagents with the quarterly TEa as the standard.Results 181 samples were enrolled in this study.The correlation coefficients of vanadate oxidation method for detecting DBIL and TBIL were more than 0.975,which were better than those of diazo method.Passing-Bablok regression analysis showed that the proportional and system errors of vanadate oxidation method were smaller.The consistency analyses showed a well-consistency between vanadate oxidation reagents,and the CCC was more than 0.99.Results at medical decision levels revealed that DBIL and TBIL reagents of vanadate oxidation method met the 1/4 TEa standard,while DBIL reagents of diazo method were outside the range of 1/4 TEa standard at 6.8μmol/L level.Conclusion Different reagents of vanadate oxidation method have a good comparability,and the comparability between different detection principles of diazo and vanadate oxidation methods is poor.

关 键 词：重氮法 钒酸盐氧化法 总胆红素 直接胆红素 

分 类 号：R446.1[医药卫生—诊断学]