Based On Colloidal Gold Immune Chromatography Technology Of Retinol Binding Protein Detection Reagent Preparation And Clinical Validation

Since human entered the21st century, with the development of nanotechnology,peoples lives have changed a lot. The development of the nanotechnologybased on modern advanced technology not only promotes the development of someother subjects, but comes into existence many new interdisciplines as well. Nanobiological technology， one of the frontier subjects today， is composed ofnanotechnology and the life science and has a bright future for the industrydevelopment. Colloidal gold immunochromatography assay (GICA) is a soliddetection technology which combines the labeling technology of colloidal gold andimmunodetection technology with chromatography.Its advantages include rapid,sensitive, safe and cheap etc.Retinol-binding protein is a specific transport protein forvitamin A in human blood circulation, Its function is transporting vitamin A from theliver to the other Tissues.Kidney takes a very important role in regulating themetabolism of a variety of vitamins, vitamins are reabsorbed through the tubularfiltration. When tubular injured,the function of reabsorption will be changed, theconcentration of RBP in the urine increased significantly. RBP is recognized as a goodmarker for early diagnostic of tubular injury. RBP detection has been widely used inclinical diagnosis of kidney disease.This article is committed to the preparation of a colloidal goldimmunochromatography assay for retinol-binding protein, providing a fast, easy andcheap assay for the diagnosis of kidney disease and popularize the early screening ofkidney disease in a large-scale.(1) Use colloidal gold immunochromatography technology to preparedetection kit of retinol-binding protein. Experiments on the preparation of detectionreagents were explored， introduce method of preparation colloidal goldimmunochromatography assay of retinol-binding protein assay; conduct functiontest, assess the performance of the detection reagents roundly. Experimental resultsshow that, the sensitivity of the detection reagent is300ng/mL,specificity,reproducibility and Batch difference are perfect,The reagent can keep stable for20days in37℃.(2) Start clinically validation test of the GICA of RBP. Comparing with listedkit (RBP detection kit, produced by Shanghai Sun Biotechnology Co., Ltd.) andanalysis the relativity of test results. The two detection methods, diagnosticconsistency (No.1hospital: K=0.9070,95%CI:0.8277~0.9863, P <0.01; No.6hospital: K=0.9391,95%CI:0.8714~1.000, P <0.01). The sensitivity and specificityof the colloidal gold immunochromatography assay for diagnosis renal tubulardamage, No.1hospital: sensitivity=100%, exact95%CI:92.45%~100.00%;specificity=91.80%, exact95%CI:81.90%~97.28%; No.6hospitals:sensitivity=100%, exact95%CI:92.45%to100.00%; specificity=91.80%, exact95%CI:81.90%~97.28%.