Abstract：
Urine retinol-binding protein 4 (RBP4) has recently been reported as a novel earlier biomarker of chronic kidney disease (CKD) which is a global public health problem with high morbidity and mortality. Accurate and rapid detection of urine RBP4 is essential for early monitor of impaired kidney function and prevention of CKD progression. In the present study, we developed a time-resolved fluorescence immunochromatographic test strip (TRFIS) for the quantitative and rapid detection of urine RBP4. This TRFIS possessed excellent linearity ranging from 0.024 to 12.50 ng/mL for the detection of urine RBP4, and displayed a good linearity (Y = 239,581 × X + 617,238, R2 = 0.9902), with the lowest visual detection limit of 0.049 ng/mL. This TRFIS allows for quantitative detection of urine RBP4 within 15 min and shows high specificity. The intra-batch coefficient of variation (CV) and the inter-batch CV were both < 8%, respectively. Additionally, this TRFIS was applied to detect RBP4 in the urine samples from healthy donors and patients with CKD, and the results of TRFIS could efficiently discern the patients with CKD from the healthy donors. The developed TRFIS has the characteristics of high sensitivity, high accuracy, and a wide linear range, and is suitable for rapid and quantitative determination of urine RBP4.
摘要：
尿视黄醇结合蛋白4（RBP4）最近被报道为慢性肾脏疾病（CKD）的新型早期生物标志物，CKD是一个具有高发病率和死亡率的全球性公共卫生问题。准确、快速检测尿液RBP4对于早期监测肾功能受损和预防CKD进展至关重要。在本研究中,我们开发了一种时间分辨荧光免疫层析试纸条（TRFIS），用于定量和快速检测尿液RBP4。该TRFIS对尿液RBP4的检测具有良好的线性，范围为0.024至12.50ng/mL，并且具有良好的线性（Y=239,581×X617,238，R2=0.9902）。最低视觉检测限为0.049ng/mL。该TRFIS允许在15分钟内定量检测尿液RBP4，并显示出高特异性。批内变异系数(CV)和批间CV均<8%,分别。此外,该TRFIS用于检测健康供体和CKD患者尿液中的RBP4，TRFIS的结果可以有效地辨别CKD患者和健康供体。开发的TRFIS具有高灵敏度的特点，精度高,和宽的线性范围，适用于尿液RBP4的快速定量测定。
