免疫透射比浊法与溴甲酚绿染色法测定血清白蛋白浓度1000例样本方法学比较及偏倚评估  

Determination of serum concentration of serum albumin by turbidimetric immunoassay method and bromocresol green staining method of 1000 samples:methodological comparison and bias evaluation

作　　者：冯品宁[1] 姚真荣[1] 徐鸿绪[1] 陈渡波[1] 林文彬[1] 甘文佳[1] 

机构地区：[1]中山大学附属第一医院医学检验科,广东广州510080

出　　处：《中国卫生检验杂志》2017年第15期2231-2234,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的研究溴甲酚绿染色法检测血清白蛋白浓度非特异性反应物质的影响,为尚在使用此方法学的实验室提供参考依据。方法依据美国临床和实验室标准协会(CLSI)标准化文件EP9-A2,收集患者血清样本1 000份,分别用免疫透射比浊法与溴甲酚绿染色法进行双份测定。以CLIA'88规定的总允许误差(ALB±10%)的1/2作为方法学比较系统误差的允许限值,进行偏倚的评估。结果 2种方法测定血清白蛋白浓度存在偏差,在医学决定水平20 g/L、25 g/L、30 g/L、35 g/L、52 g/L时,染色法相对偏倚分别为23.25%、13.96%、7.77%、3.31%、-5.37%;根据EP9-A2预期偏倚在95%可信限内。结论溴甲酚绿染色法检测血清白蛋白浓度由于受球蛋白和转铁蛋白等非特异性反应物质影响,正常值以下检测结果偏高,浓度越低,偏差越大。对实验室结果产生误导,必须引起实验室和临床的重大关注。Objective To study the effects of nonspecific reactants in serum albumin detection by bromocresol green staining method,so as to provide reference for the laboratory which is still using this method. Methods According to the CLSI standardization document,EP9-A2,the serum samples collected from 1 000 patients were measured twice by turbidimetric immunoassay and bromocresol green staining method respectively. The maximum system error was designated as the half of total allowable error（ ALB ± 10%） ruled by CLIA＇88. The assessment of bias was done based on this maximum system error. Results Serum albumin concentrations detected by these two methods were different. At the medical decision levels of 20 g/L,25 g/L,30 g/L,35 g/L,52 g/L,the relative deviations of bromocresol green staining method were 23. 25%,13. 96%,7. 77%,3. 31%,-5. 37%,respectively,which were within the 95% confidence limit according to the EP9-A2 expectation bias. Conclusion The concentration of serum albumin was measured by Bromocresol green staining method. Because of the effects of non specific reaction substances,such as globulin and transferrin,the detection result under normal value was higher,and the concentration is lower,the deviation will be greater,which can bring misleading to the laboratory results. It must be a major concern in clinical and laboratory.

关 键 词：血清白蛋白 免疫透射比浊法 溴甲酚绿染色法 偏倚 

分 类 号：R446.1[医药卫生—诊断学]