3种肌酐测定方法的分析性能评价  

Appraisal of three plasma creatinine test methodology

作　　者：王美珠 康伟 黄勤烽 陈敏[1] WANG Meizhu;KAN Wei;HUANG Qinfeng;CHEN Min(Department of Clinical Laboratory,Fuzhou General Hospital,Fuzhou,Fujian 350025,China)

机构地区：[1]福州总医院检验科/全军检验医学研究所,福建福州350025

出　　处：《国际检验医学杂志》2019年第1期62-65,70,共5页International Journal of Laboratory Medicine

基　　金：福建省科技重点项目(2012Y0058)

摘　　要：目的系统评价亚胺水解酶法(简称紫外酶法)、肌氨酸氧化酶法(简称氧化酶法)及苦味酸法测定肌酐的分析性能。方法按美国临床和实验室标准化协会EP5-A2、EP6-A、EP9-A2、EP7-A2等文件要求,采用罗氏Cobas c702全自动生化分析仪对3种肌酐测定方法的精密度、线性范围、可报告范围、方法学比对、药物干扰、试剂稳定性等性能指标进行评价。结果紫外酶法、氧化酶法及苦味酸法的批内精密度和批间精密度分别小于1/4允许总误差(TEa)和1/3TEa。紫外酶法、氧化酶法及苦味酸法的线性范围分别为4～2 017、8～1 966、3～1 310μmol/L;可报告范围分别为4～20 160、8～51 900、3～10 080μmol/L。3种方法具有良好的相关性(R2>0.99)。羟苯磺酸钙≥5.24μg/mL、酚磺乙胺≥0.016g/L时氧化酶法存在负干扰;其他2种方法在药物的最大剂量下不受干扰。苦味酸法在不定标的情况下待机在控时间只有2d,随后检测结果逐日明显下降,而其他2种方法稳定性较好。结论紫外酶法是3种肌酐测定方法中最为可靠的方法。Objective To evaluate the results of plasma creatinine determined by imide Hydrolase method(hereinafter referred to as UV enzymatic method),sarcosine oxidase enzymatic method and Jaffémethod on biochemical Analyzer Cobas 8000 c702.Methods According to the American clinical and laboratory Standards Institute(CLSI)guidelines EP5-A2,EP6-A,C28-A2,EP9-A2,EP7-A2 and other documents,the precisions,linear ranges,reportable ranges,methodological comparisons,drug interferences,reagents stability of three methods for determination of creatinine were evaluated.Results The within-run precision and between-run precision of three methods were less than 1/4TEa and 1/3Tea,respectively.The linear ranges of UV enzymatic method,sarcosine oxidase enzymatic method and Jaffémethod were 4-2 017μmol/L,8-1 966.5μmol/L,and 3-1 310.5μmol/L respectively,and their reportable ranges were as follows:4-20 160μmol/L,8-51 900μmol/L and 3-10 080μmol/L.The methodological comparison shows that these three above-mentioned methods correlate to each other very well with a correlation coefficient of more than 0.99.However,in interference test,we found that the sarcosine oxidase enzymatic method of creatinine quantification could be affected significantly by the negative interference of the presence of 5.24μg/mL calcium dobesilate or 0.016 g/L etamsylate,but there were no marked difference in the other two methods even under the maximum dose.In the stability of reagent within the instrument after open,the reagents of Jaffémethod without calibration could maintain stability only two days and show obvious decreasing trend,but the reagents were more stable in the other two methods.Conclusion Based on the above data,we presented the view that UV enzyme method is the most reliable in these three above-mentioned methods of detecting creatinine.

关 键 词：肌酸酐 亚胺类 肌氨酸氧化酶 苦味酸盐类 临床酶试验 

分 类 号：R446.11[医药卫生—诊断学]