快速检测尿微量白蛋白的半定量金免疫渗滤法的研究

目的　建立一种伴有质控点的金免疫渗滤法 ,用于半定量检测人尿中的微量白蛋白。方法　应用自制的 2株抗人白蛋白单克隆抗体 ,其中一株包被在固相膜上 ,另一株与胶体金结合 ,组成金免疫渗滤试剂。膜上另包被 2种浓度的人白蛋白 ,用于测定时的定量质控。结果　本法经人白蛋白标准液测定 ,结果判定可分为 <30、30～ 10 0、10 0～ 2 0 0、>2 0 0mg/L 4个半定量区 ;12 6例经散射免疫浊度定量测定白蛋白浓度的临床尿标本用于本法的对比测定 ,结果符合性良好。结论　本法具有半定量和质控的特点 ,结果可靠 ,适用于糖尿病、高血压等并发肾病的早期诊断 ,方法简便、快速 ,特别适合中、小医院和门诊部使用。

Studies on the semi-quantitative gold immunofiltration assay for rapid detection of microalbuminuria

Objective To develop a semi-quantitative gold immunofiltration assay (GIFA) with quality control dots for the detection of microalbuminuria. Methods The GIFA kit was developed with two self-prepared anti-human-albumin monoclonal antibodies,one of which was immobilized on the membrane and the other was labeled with gold sol. Two human albumin dots of different concentrations were immobilized also on the membrane for the quantitative quality control of the assay. Results Determination of human albumin standard solution showed that result of GIFA could divided into four semi-quantitative albumin levels:<30,30 to 100,100 to 200 and >200 mg/L. Simultaneous determination of 126 clinical urine samples by quantitative nephelometric immunoassay and GIFA gave coincident results. Conclusions The GIFA for microalbuminuria is semi-quantitative and quality controllable. It is reliable and suitable for clinical use in the early diagnosis of diabetic and hypertensive nephropathy. It is simple and rapid and especially useful for middle and small scale hospitals and clinics.