Department of Mechanical Engineering, University of Hawaii at Manoa, Honolulu, HI 96822, USA.
Querrey Simpson Institute for Bioelectronics, Northwestern University, Evanston, IL 60202, USA.
Sci Transl Med. 2021 Mar 31;13(587). doi: 10.1126/scitranslmed.abd8109.
The concentration of chloride in sweat remains the most robust biomarker for confirmatory diagnosis of cystic fibrosis (CF), a common life-shortening genetic disorder. Early diagnosis via quantitative assessment of sweat chloride allows prompt initiation of care and is critically important to extend life expectancy and improve quality of life. The collection and analysis of sweat using conventional wrist-strapped devices and iontophoresis can be cumbersome, particularly for infants with fragile skin, who often have insufficient sweat production. Here, we introduce a soft, epidermal microfluidic device ("sweat sticker") designed for the simple and rapid collection and analysis of sweat. Intimate, conformal coupling with the skin supports nearly perfect efficiency in sweat collection without leakage. Real-time image analysis of chloride reagents allows for quantitative assessment of chloride concentrations using a smartphone camera, without requiring extraction of sweat or external analysis. Clinical validation studies involving patients with CF and healthy subjects, across a spectrum of age groups, support clinical equivalence compared to existing device platforms in terms of accuracy and demonstrate meaningful reductions in rates of leakage. The wearable microfluidic technologies and smartphone-based analytics reported here establish the foundation for diagnosis of CF outside of clinical settings.
汗液中氯的浓度仍然是囊性纤维化 (CF) 确诊的最有力生物标志物,CF 是一种常见的缩短寿命的遗传疾病。通过定量评估汗液中的氯,早期诊断可以及时开始治疗,这对延长预期寿命和提高生活质量至关重要。使用传统的腕带设备和离子电渗法收集和分析汗液可能很麻烦,特别是对于皮肤脆弱的婴儿,他们往往汗液分泌不足。在这里,我们介绍了一种柔软的表皮微流控装置(“汗液贴纸”),旨在简单快速地收集和分析汗液。与皮肤的紧密、贴合耦合支持几乎完美的汗液收集效率,不会发生泄漏。实时分析氯化物试剂的图像可以使用智能手机摄像头进行定量评估氯离子浓度,而无需提取汗液或进行外部分析。涉及 CF 患者和健康受试者的临床验证研究涵盖了不同年龄组,与现有设备平台相比,在准确性方面具有临床等效性,并证明泄漏率有明显降低。本文报道的可穿戴微流控技术和基于智能手机的分析为临床外 CF 的诊断奠定了基础。