评价胆红素对肌氨酸氧化酶法测定肌酐的干扰  

Evaluation of Biliruin Interference of Creatinine by Sarcosine Oxidase Method

作　　者：张淑华[1] 李云凤[1] 赵宝鹤 张吉奎 杨亚轩 高文育 徐福海[1] 郑福和[1] 于水江[1] 王华新[1] ZHANG Shu- hua LI Yun- feng ZHAO Bao- he ZHANG Ji- kui YANG Ya- xuan GAO Wen-yu XU Fu-hai ZHENG Fu-he YU Shui-jiang WANG Hua-xin(Boai Hospital of Huanghua City,Huanghua 061100 ,China)

机构地区：[1]黄骅开发区博爱医院,河北黄骅061100 [2]唐山市丰润区疾控中心,河北唐山063000

出　　处：《标记免疫分析与临床》2016年第12期1473-1477,共5页Labeled Immunoassays and Clinical Medicine

基　　金：河北省卫计委指令性课题(1120140226)

摘　　要：目的评价胆红素对肌氨酸氧化酶法测定肌酐(Cr)的干扰。方法随机选择国内威高、长征、九强、生之源、基蛋、利德曼6种肌氨酸氧化酶法Cr试剂盒,按照美国临床实验室标准化协会EP 7-A2文件中"配对差异"和"剂量效应"方案,在正常和高值Cr血清中添加不同浓度结合胆红素(CBIL)和游离胆红素(FBIL)干扰物,进行干扰评价试验。结果 CBIL和FBIL对肌氨酸氧化酶法测定Cr存在不同程度的干扰。Cr正常水平,CBIL和FBIL≥120μmol/L时对威高、基蛋Cr试剂产生明显干扰,CBIL≥621μmol/L或FBIL≥481μmol/L时对九强、生之源、长征Cr试剂产生干扰;Cr高值水平,CBIL或FBIL≥120μmol/L时对威高Cr试剂产生干扰,CBIL≥962μmol/L或FBIL≥1083μmol/L时对长征Cr试剂产生干扰。干扰所产生的相对偏倚差异显著,CBIL较比FBIL干扰作用更加明显。"剂量效应"结果显示,胆红素对Cr测定产生负干扰并呈线性关系。结论国内肌氨酸氧化酶法测定Cr试剂抗胆红素干扰能力不同,胆红素对Cr测定产生负干扰并呈线性关系。临床实验室在应用肌氨酸氧化酶法测定Cr时应进行胆红素干扰试验验证。Objective To investigate the interference and result bias of bilirubin by Sarcosine oxidase method in determination of creatinine. Methods To evaluate the anti-interference ability, we randomly selected 6 kinds of Sarcosine oxidase method for the determination of creatinine （WEIGAO, CHANGZHENG, SHENGZHIYUAN, JIUQIANG, JIDAN, LIDEMAN）. According to the ＂paired difference＂ and ＂dose- response＂ documents from Clinical and Laboratory Standards Institute NCCLS EP7-A2, the interference tests were conducted by adding different concentrations of conjugated bilirubin （CBIL） and freed bilirubin （FBIL） to normal and high levels creatinine in serum. Results The CBIL and FBIL had different degrees of interference to the determination of creatinine, but the anti-interference ability of the reagents was different. At normal creatinine level, WEIGAO or JIDAN revealed interference when CBIL and FBIL ≥ 120μmol/L. When CBIL ≥621 μmol/L or FBIL≥481 μmol/L, JIUQIANG, SHENGZHIYUAN and CHANGZHENG revealed interference. At high creatinine levels, WEIGAO also demonstrated interference with CBIL or FBIL ≥120μmol/L, CHANGZHENG with ≥962 μmol/L CBIL and CHANGZHENG with ≥ 1083 μmol/L FBIL respectively. The relative bias caused by interference was significantly different. The CBIL interference effect was more obvious than the FBIL. The results of ＂dose-response＂ showed that there was a negative interference in the determination of serum creatinine with bilirubin, and there was a linear function relationship. Conclusion The interference ability of anti bilirubin interference in the determination of creatinine reagent was different, and there was a negative interference in the determination of serum creatinine with bilirubin and there was a linear function with them. Clinical laboratories should always conduct validation of bilirubin interference for the determination of creatinine by sarcosine oxidase method.

关 键 词：肌氨酸氧化酶法 肌酐 胆红素干扰 干扰试验 

分 类 号：R446.1[医药卫生—诊断学]