应用EP7-A2文件探讨溶血对重氮法测定总胆红素的干扰情况  

Application of EP7-A2 document for investigating interference of hemolysis on total bilirubin detection by diazonium method

作　　者：管华玲 吴健 王源[2] 张汉东[3] 

机构地区：[1]盐城市第一人民医院检验科,江苏盐城224005 [2]浙江省中医院检验科,浙江杭州310006 [3]盐城市第三人民医院检验科,江苏盐城224001

出　　处：《国际检验医学杂志》2015年第24期3525-3526,3529,共3页International Journal of Laboratory Medicine

基　　金：浙江省医药卫生科技计划资助项目(2015YB262)

摘　　要：目的应用EP7-A2文件评价溶血对临床总胆红素测定的干扰。方法依据EP7-A2文件要求的"配对-差异"实验对干扰物进行确认,并使用"剂量-效应"实验来分析干扰物浓度与干扰程度之间的关系。结果 "配对-差异"实验结果显示5g/L血红蛋白对A、B两种总胆红素试剂均有负干扰,但A试剂盒明显受溶血干扰程度小;"剂量-效应"实验结果显示血红蛋白对总胆红素检测A试剂盒可产生线性负干扰,低值标本的线性方程为Y=-0.146 X+14.1,r=0.964,中值标本的线性方程为Y=-0.546 X+92.24,r=0.947,高值标本的线性方程为Y=-1.153 X+307.2,r=0.979。结论溶血对临床总胆红素测定的有线性负干扰,可以利用标本的血红蛋白浓度对总胆红素的值进行校正;EP7-A2文件在分析干扰评价方面具有一定的应用价值。Objective To apply EP7-A2 document for evaluating the interference of hemolysis the total bilirubin detection in clinic.Methods The interferent was affirmed according to the ＂paired-difference＂ test required by the EP7-A2 document.The relation between interferent concentration and interference degree was analyzed by using the ＂ dose-effect＂ test.Results The ＂paireddifference＂ test results showed that 5.00g/L hemoglobin had negative interference effect on two kinds of total bilirubin reagents.But the reagent kit A had little interference degree of hemolysis;The dose-effect test results showed that hemoglobin produced the linear negative interference effect on the reagent kit A of total bilirubin detection.The linear equation of low value sample was Y=-0.146 X＋14.1,r=0.964,which of middle value sample was Y=-0.546 X＋92.24,r=0.947 and which of high value sample was Y=-1.153 X＋307.2,r=0.979.Conclusion Hemolysis has a negative interference effect on total bilirubin detection in clinic.The total bilirubin value could be corrected by using the hemoglobin concentration of sample;the EP7-A2 document has certain application value in the aspect of analyzing interference and evaluation.

关 键 词：总胆红素 重氮法 EP7-A2文件 干扰实验 

分 类 号：R446.1[医药卫生—诊断学]