自制尿微量白蛋白试剂盒在生化分析仪上的临床应用

Clinical application of reagent box for urinary microalb detected at auto biochemical analyzer

采用自制的羊抗人白蛋白血清，以免疫透射比浊法的原理，用双试剂多点定标法在全自动生化分析仪上建立检测尿微量白蛋白的方法学。方法反应稳定；特异柱强；重复性好；光明显干扰因素。白蛋白浓度在0～200mg／L范围内线性良好。批内误差CV＝1．99％～2．37％；批间误差CV＝2.61％～3．46％，平均回收率98．7％；灵敏度为12.5mg／L。分别检测387例健康者，68例糖尿病患者，34例肾病患者尿中微量白蛋白，含量分别为11．5±10．5mg／L，66．4±49．6mg／L，97．8±60．8mg／L。经统计学处理，糖尿病和肾病患者尿中微量白蛋白均明显高于健康对照组（P＜0．01）。以百分位统计法确定正常参考值为0～22．5mg／L。

To established a method that applicated the principle of immunoturbidimetry and double reagent multi -pointed calibration, detected urinary micro - Alb with anti - Alb produced by sheep. The reaction of the method shows well stability and specificity as well as reproducibility, and has no significant interference. The quantitative range is 0~200mg/L. The CV of intra-assay and inter-assay were 1. 99% ~2. 77% and 2- 61 %~3. 46% respectively. The average recovery rate was 98. 7%. The sensitivity is 12. 5 % mg/L. The specimens of 378 healthy, 68 diabetes mellitus(DM) And 34 nephrotic syndome subjects have been detected. The result were 11. 5 ±10. 5 mg/L. 66. 4 ± 49. 6 mg/L, 97. 8±60. 8 mg/L respectively. The urinary micro -Alb of DM and nephortic syndrome subjects is significantly higher than of healthy (P<0. 01). The normal range was found that is 0~22. 5 mg/L.