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Paper-Based Device for Naked Eye Urinary Albumin/Creatinine Ratio Evaluation.
ACS Sensors ( IF 8.9 ) Pub Date : 2020-03-18 , DOI: 10.1021/acssensors.0c00050
Ryuya Hiraoka,Kento Kuwahara,Yun-Chiao Wen,Tzung-Hai Yen,Yuki Hiruta,Chao-Min Cheng,Daniel Citterio

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.

中文翻译:

基于纸的裸眼尿白蛋白/肌酐比值评估装置。

本文介绍了“ Drawing-PADs”(基于绘图纸的微流分析设备)的概念,可以直观地评估尿白蛋白(Alb)指数,这是一种用于早期发现与糖尿病有关的肾功能不全的临床重要参数。 。为了能够定期监测Alb指数,非常需要一种适合自我诊断的简单检查方法。根据基于距离的微流体PAD(μPAD)方法,Drawing-PAD依赖于在单个设备上同时肉眼检测Alb和肌酐(Cre)。通过简单地绘制一条连接两个颜色变化的测定通道部分(Alb和Cre通道)顶部的直线,然后在视觉上确认绘制的直线的截距的位置,即可显示Alb指数。使用Drawing-PAD执行的半定量Alb指数评估不需要任何设备,例如照相机,软件或颜色参考表。所得结果与样品量无关,不受尿液排泄量变化引起的绝对Alb和Cre浓度变化的影响,从而使尿液现场测定成为可能。根据临床相关标准(正常白蛋白尿,微量白蛋白尿和大型白蛋白尿)对Alb指数值进行分类很容易在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。所得结果与样品量无关,不受尿液排泄量变化引起的绝对Alb和Cre浓度变化的影响,从而使尿液现场测定成为可能。根据临床相关标准(正常白蛋白尿,微量白蛋白尿和大型白蛋白尿)对Alb指数值进行分类很容易在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。所得结果与样品量无关,不受尿液排泄量变化引起的绝对Alb和Cre浓度变化的影响,从而使尿液现场测定成为可能。根据临床相关标准(正常白蛋白尿,微量白蛋白尿和大型白蛋白尿)对Alb指数值进行分类很容易在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。
更新日期:2020-03-18
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