尿微量清蛋白检测试剂盒分析性能初步评价  

Preliminary evaluations on kit of urine micro albumin determination

作　　者：鄢仁晴[1] 吴昌猛[1] 黄美容[2] 

机构地区：[1]遵义医学院附属医院检验科,贵州遵义563003 [2]遵义医学院医学检验系,实习生贵州遵义563003

出　　处：《检验医学与临床》2009年第15期1257-1258,共2页Laboratory Medicine and Clinic

摘　　要：目的通过德赛公司尿微量清蛋白(UmAlb)免疫比浊法试剂盒分析性能的测定,评价UmAlb测定方法的临床应用价值。方法采用全自动生化分析仪OLYMPUS AU2700对该试剂盒精密度、准确度、特异性等指标进行评价。结果批内和批间变异系数分别为1.56%～4.70%和2.10%～10.12%,平均回收率为109.64%,低于27.05 mmoL/L的葡萄糖溶液和低于0.05 g/L的维生素C(VitC)对UmAlb检测无显著干扰。UmAlb在0～300 mg/L内线性良好。结论目前使用的UmAlb免疫比浊试剂盒重复性尚可,准确性欠佳,线性范围良好,不受低于27.05 mmoL/L的葡萄糖溶液和低于0.05 g/L的VitC的干扰。建议购买mAlb检测质控液进行室内质控,以提高实验室检测结果的准确性和重复性,满足临床需要。Objective To evaluate the reliability of Urine micro albumin immunoturbidimetry determination kit. Methods Comfirm the kit pricision,accuracy,specificity and interference by full automatic biochemistry analyzer OLYMPUS AU2700 . Results The chemical characters evaluation showed that the intraassay coefficient of variation is from 2.75 to 4.7% ; the intraassay coefficient of variation is from2.1 to 10.12%; and the average recovery rate is 109.64%. The assay have no significant interferences by glucose solution concentration less than or equal to 27.05 mmoL/L and Vitamin C strength less than or equal to 0.05g, and there are good linearity in 0-300 mg/L. Conclusion The Pricision of the result of kit of UmAlb determined by this method illustrated above is reliable, but the accuracy is not reliable. Advocate to buy a quality control in order to increase the pricise result in the clinical laboratory.

关 键 词：微量清蛋白尿 诊断试剂盒 散射测浊法和比浊法 评价研究 

分 类 号：R446.12[医药卫生—诊断学]