关键词: 尿微量白蛋白, 荧光免疫层析, 快速检测

Abstract: This work aims to develop a rapid quantitative detecting method of fluorescence immunochromatographic assay（FICA）for human urinary microalbuminuria（MAU）. The fluorescence immunochromatographic strips were successfully prepared with anti-human albumin monoclonal antibody and goat anti-rabbit IgG marked by carboxyl fluorescent microspheres as the detection antibody,human albumin as the test line,and the rabbit IgG as the control line. As the results showed,the linear range of prepared kit（i.e.,fluorescence immunochromatographic strips）was in 5 mg/L-300 mg/L with a detection limit of 2.3 mg/L. The intra- and inter-assay coefficient of variation was 6.4%-9.3% and 6.5%-12.3%,respectively. The average recovery percent was 102.3%. The kit showed solid specificity as there was no cross-reactivity with 20 kinds of interfering substances. The shelf time of the kit by real-time stability test was > 12 months. Test with clinical urinary samples by the kit showed high correlation（r = 0.993,P < 0.01）with the control Orion QuikRead U-ALB kit,and Bland-Altman analysis showed that the diagnostic results of the two methods presented promising consistency. In conclusions,the prepared fluorescence immunochromatographic kit provides a simple,rapid and accurate quantitative detection method for microalbuminuria.

Key words: microalbuminuria, fluorescence immunochromatography, rapid detection