速率法检测血清α-L-岩藻糖苷酶(AFU)改良试剂中添加烷基糖苷的实验性能评价  

Experimental Performance Evaluation of Alkyl Glycosides Added to Improved Reagent for Detection of Serum α-L-fucosidase(AFU)by Rate Method

作　　者：崔倩 耿志欣 吴娟[1] 王梦林 裴兵 CUI Qian;GENG Zhixin;WU Juan;WANG Mengin;PEI Bing(Department of Clinical Laboratory,the First People’s Hospital of Suqian City Affiliated to Nanjing Medical University,Jiangsu Suqian 223800,China)

机构地区：[1]南京医科大学附属宿迁市第一人民医院医学检验科,江苏宿迁223800

出　　处：《现代检验医学杂志》2023年第4期159-162,共4页Journal of Modern Laboratory Medicine

基　　金：宿迁市科技重点实验室项目(M201902)。

摘　　要：目的探讨添加烷基糖苷(alkylglycosides,APG)改良试剂速率法检测血清α-L-岩藻糖苷酶(α-L-fucosidase,AFU)的实验性能评价。方法通过优化反应体系,对速率法检测AFU改良试剂的精密度、线性范围、干扰性、结果比对及稳定性进行实验。结果改良试剂精密度为批内CV低中高值分别为2.10%,1.19%和0.67%;批间CV低中高分别为2.62%,1.90%和1.20%,且两组试剂结果表明差异均有统计学意义(均P<0.01)。线性实验显示方程为Y=1.0045X-0.5485,相关系数r^(2)=0.9997,线性范围0~300U/L。干扰实验表明样本中抗坏血酸≤12g/L,胆红素≤550μmol/L,脂血指数≤0.5mg/L,血红蛋白≤3g/L,对改良试剂无干扰。同时与进口试剂比对实验回归方程为Y=0.9978X+0.0853,相关性良好(r^(2)=0.9998)。稳定性实验结果显示改良试剂在2~8℃存放12个月测定结果稳定,CV低值=1.04%,CV高值=1.18%。结论改良试剂的精密度、线性范围、干扰性、稳定性更加符合国家质量标准,适合全自动生化分析仪使用。Objective To evaluate the experimental performance of the rate method for the detection of serumα-L-fucosidase(AFU)by adding alkyl polyglucoside(APG).Methods By optimizing the reaction system,the precision,linear range,interference,result comparison and stability of the improved reagent for AFU detection by rate method were tested.Results The precision of the improved reagent was 2.10%,1.19%and 0.67%,for the low,medium and high values of CV in the batch respectively.The low,middle and high CV between batches were 2.62%,1.90%and 1.20%,respectively,and the difference between the two groups of reagents showed statistical significance(all P<0.01).The linear experiment shows that the equation was Y=1.0045X-0.5485,the correlation coefficient r^(2)=0.9997,and the linear range was 0~300U/L.The interference experiment showed that ascorbic acid≤12g/L,bilirubin≤550μmol/L,hyperlipidemia index≤0.5mg/L and hemoglobin≤3g/L in the sample had no interference with the improved reagent.At the same time,compared with imported reagents,the regression equation was Y=0.9978X+0.0853,and the correlation was good(r^(2)=0.9998).The stability test results show that the improved reagent was stable after being stored at 2~8℃for 12 months,with CVlow=1.04%and CVhigh=1.18%.Conclusion The precision,linear range,interference and stability of the improved reagent are more in line with the national quality standards,so it is suitable for automatic biochemical analyzer.

关 键 词：α-L-岩藻糖苷酶(AFU) 烷基糖苷(APG) 性能验证 全自动生化仪 

分 类 号：R446.112[医药卫生—诊断学]