[1]崔 倩,耿志欣,吴 娟,等.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[J].现代检验医学杂志,2023,38(04):159-162.[doi:10.3969/j.issn.1671-7414.2023.04.029]
　CUI Qian,GENG Zhixin,WU Juan,et al.Experimental Performance Evaluation of Alkyl Glycosides Added to Improved Reagent for Detection of Serum α-L-fucosidase (AFU) by Rate Method[J].Journal of Modern Laboratory Medicine,2023,38(04):159-162.[doi:10.3969/j.issn.1671-7414.2023.04.029]
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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()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第38卷
期数:
2023年04期
页码:
159-162
栏目:
研究简报·实验技术
出版日期:
2023-07-15

文章信息/Info

Title:
Experimental Performance Evaluation of Alkyl Glycosides Added to Improved Reagent for Detection of Serum α-L-fucosidase (AFU) by Rate Method
文章编号:
1671-7414（2023）04-159-04
作者:
崔 倩; 耿志欣; 吴 娟; 王梦林; 裴 兵
（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）
Author(s):
CUI Qian; GENG Zhixin; WU Juan; WANG Menglin; PEI Bing
（Department of Clinical Laboratory, the First People’s Hospital of Suqian City Affiliated to Nanjing Medical University, Jiangsu Suqian 223800,China）
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
DOI:
10.3969/j.issn.1671-7414.2023.04.029
文献标志码:
A
摘要:
目的　探讨添加烷基糖苷（alkyl glycosides, 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-0.548 5，相关系数r2=0.999 7，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=0.9978 X+0.085 3，相关性良好（r2=0.999 8）。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。
Abstract:
Objective　To evaluate the experimental performance of the rate method for the detection of serum α-Lfucosidase (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=1.004 5X-0.548 5, the correlation coefficient r2=0.999 7, 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=0.997 8X+0.085 3, and the correlation was good (r2=0.999 8). 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.

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备注/Memo

备注/Memo:
基金项目：宿迁市科技重点实验室项目（M201902）。
作者简介：崔倩（1986-），女，硕士，主管检验技师，主要从事临床生物化学，E-mail：sqfhccl@126.com。
通讯作者：裴兵（1972-），男，硕士，主任技师，主要从事肿瘤早期筛查，E-mail：sqpeibing@njmu.edu.cn。
更新日期/Last Update: 2023-07-15