检验医学 ›› 2013, Vol. 28 ›› Issue (9): 820-823.DOI: 10.3969/j.issn.1673-8640.2013.09.021

• 技术研究与评价.论著 • 上一篇    下一篇

高压液相色谱检测糖尿病患者尿白蛋白的应用

史梅,史伟峰,李燕梅   

  1. 常州市第一人民医院检验科,江苏 常州 213003
  • 收稿日期:2012-08-09 修回日期:2013-09-25 出版日期:2013-09-15 发布日期:2013-09-25
  • 作者简介:史 梅,女,1976年生,硕士,副主任技师,主要从事临床免疫检验工作。

The application of the determination of urinary albumin by HPLC in patients with diabetes mellitus

SHI Mei,SHI Weifeng,LI Yanmei.   

  1. Department of Clinical Laboratory,the First People′s Hospital of Changzhou,Jiangsu Changzhou 213003,China
  • Received:2012-08-09 Revised:2013-09-25 Online:2013-09-15 Published:2013-09-25

摘要:

目的 探讨高效液相色谱法(HPLC)测定糖尿病(DM)患者尿白蛋白的应用。方法 收集85例DM患者及40名健康体检者(正常对照组)尿液,分别用HPLC和免疫比浊法检测尿白蛋白,并将检测结果使用回归和Bland-Altman进行一致性分析。结果 HPLC线性方程为Y=2.948 2X+38.601,r2=0.994 4;标准品和样本的保留时间(RT) 均为2.42 min;尿白蛋白浓度为40.1和152.6 mg/L的样本其批内和批间变异系数(CV)分别为4.1%、4.8%和5.6%、6.5%;最低检测限为2 mg/L。DM组尿白蛋白HPLC结果为21.0(3.4~678.9)mg/L,高于免疫比浊法[8.2(2.0~442.2)mg/L](P<0.01),但偏高的倍数不一致(1.3~6.1倍);但正常对照组2种方法测定结果差异无统计学意义(P>0.05)。将2种方法的测定结果用回归分析和Bland-Altman进行一致性分析,显示2种方法的一致性较差。85例DM患者中用HPLC和免疫比浊法检测达到微量蛋白尿诊断标准[尿白蛋白排泄率(AER)>30 mg/24 h]的阳性例数分别为48例(56.5%)和27例(31.8%)。结论 HPLC能检测尿中的包括免疫性和非免疫性的总的尿白蛋白,与免疫比浊法相比更能早期检出尿白蛋白。

关键词: 白蛋白, 尿液, 高压液相色谱, 免疫化学非反应性白蛋白

Abstract:

Objective To investigate the application of urinary albumin determination by high performance liquid chromatography (HPLC) in patients with diabetes mellitus (DM). Methods Urine samples of 85 DM patients and 40 healthy subjects (healthy control group) were collected, and the urinary albumin concentrations were determined by HPLC and immunoturbidimetry respectively. The consistency of the results between the 2 methods was analyzed by the regression analysis and Bland-Altman analysis. Results HPLC linear regression equation was Y=2.948 2X+38.601,r2=0.994 4.The retention time (RT) of standard materials and samples were 2.42 min. Within-run coefficient of variation (CV) was 4.1%, and between-run CV was 5.6% at concentration of 40.1mg/L. Within-run CV was 4.8%, and between-run CV was 6.5% at concentration of 152.6 mg/L. The lowest detection limit was 2 mg/L. The urinary albumin concentration was significantly higher by HPLC [21.0(3.4-678.9)mg/L] than by immunoturbidimetry [8.2(2.0-442.2)mg/L] by 1.3-6.1 folds (P<0.01). There was no statistical significance between the concentrations of control group by HPLC and immunoturbidimetry(P>0.05). The regression analysis and Bland-Altman analysis demonstrated that the 2 methods were not consistent. Of all the 85 DM patients, according to microalbuminuria diagnosis standard [urinary albumin excretion rate (AER) >30 mg/24h], there was 48(56.5%) positive cases by HPLC and 27(31.8%) positive cases by immunoturbidimetry. Conclusions Immunity and no-immunity total urinary albumin can be determined by HPLC. Microalbuminuria in DM patients can be determined earlier by HPLC.

Key words: Albumin, Urine, High performance liquid chromatography, Immunochemically nonreactive albumin

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