Department of Applied Chemistry, Keio University, 3-14-1 Hiyoshi, Kohoku-ku, Yokohama 223-8522, Japan.
School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, Taoyuan 333, Taiwan.
ACS Sens. 2020 Apr 24;5(4):1110-1118. doi: 10.1021/acssensors.0c00050. Epub 2020 Mar 31.
This paper introduces the concept of "Drawing-PADs" (Drawing paper-based microfluidic analytical devices) allowing to intuitively evaluate the urinary albumin (Alb) index, a clinically important parameter used for the early detection of renal deficiencies related to diabetes, among others. To enable regular monitoring of the Alb index, a simple examination method suitable for self-diagnosis is highly desirable. The Drawing-PADs rely on the simultaneous naked eye detection of Alb and creatinine (Cre) on a single device according to the distance-based microfluidic PAD (μPAD) approach. The Alb index is visualized by simply drawing a straight line connecting the top of two color-changed assay channel sections (Alb and Cre channels), followed by visually confirming the position of the intercept of the drawn straight line. The semiquantitative Alb index evaluation performed with Drawing-PADs does not require any equipment such as a camera, software, or a color reference chart. The obtained results are independent of the sample volume and are not influenced by changes in the absolute Alb and Cre concentrations caused by urine excretion variations, making spot urine assays possible. Classification of Alb index values according to clinically relevant criteria (normoalbuminuria, microalbuminuria, and macroalbuminuria) is readily achieved within 15 min and has been validated for 15 human urine samples including diabetic patients and healthy volunteers.
本文介绍了“绘图-PADs”（基于绘图纸的微流控分析装置）的概念，可直观评估尿白蛋白（Alb）指数，这是一种临床重要参数，用于早期检测与糖尿病等相关的肾脏缺陷。为了实现 Alb 指数的定期监测，非常需要一种适合自我诊断的简单检查方法。绘图-PADs 依赖于根据基于距离的微流控 PAD（μPAD）方法在单个设备上同时进行 Alb 和肌酸酐（Cre）的肉眼检测。Alb 指数通过简单地绘制一条连接两个颜色变化检测通道部分（Alb 和 Cre 通道）顶部的直线来可视化，然后通过目视确认所绘制直线的交点位置。使用绘图-PADs 进行的半定量 Alb 指数评估不需要任何设备，如相机、软件或颜色参考图表。获得的结果与样品体积无关，不受由于尿液排泄变化引起的 Alb 和 Cre 浓度绝对值变化的影响，从而可以进行随机尿液检测。根据临床相关标准（正常白蛋白尿、微量白蛋白尿和大量白蛋白尿）对 Alb 指数值进行分类可在 15 分钟内完成，并已针对包括糖尿病患者和健康志愿者在内的 15 个人类尿液样本进行了验证。
