Diabetic retinopathy (DR), a chronic and progressive microvascular complication of diabetes mellitus, substantially threatens vision and is a leading cause of blindness among working-age individuals worldwide. Traditional diagnostic methods, such as ophthalmoscopy and fluorescein angiography are nonquantitative, invasive, and time consuming. Analysis of protein biomarkers in tear fluid offers noninvasive insights into ocular and systemic health, aiding in early DR detection. This study introduces a surface acoustic wave (SAW) microchip that rapidly enhances fluorescence in bead-based immunoassays for the sensitive and noninvasive DR detection from human tear samples. The device facilitated particle mixing for immunoassay formation and particle concentration in the droplet, resulting in an enhanced immunofluorescence signal. This detachable SAW microchip allows the disposal of the cover glass after every use, thereby improving the reusability of the interdigital transducer and minimizing potential cross-contamination. A preliminary clinical test was conducted on a cohort of 10 volunteers, including DR patients and healthy individuals. The results demonstrated strong agreement with ELISA studies, validating the high accuracy rate of the SAW microchip. This comprehensive study offers significant insights into the potential application of a novel SAW microchip for the early detection of DR in individuals with diabetes. By utilizing protein biomarkers found in tear fluid, the device facilitates noninvasive, rapid, and sensitive detection, potentially revolutionizing DR diagnostics and improving patient outcomes through timely intervention and management of this vision-threatening condition.

中文翻译：

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通过可拆卸表面声波免疫传感器快速筛查糖尿病视网膜病变


糖尿病视网膜病变 (DR) 是糖尿病的一种慢性进行性微血管并发症，严重威胁视力，是全世界工作年龄人群失明的主要原因。传统的诊断方法，例如检眼镜和荧光素血管造影，是非定量的、侵入性的且耗时的。对泪液中蛋白质生物标志物的分析提供了对眼部和全身健康状况的无创洞察，有助于早期 DR 检测。本研究引入了一种表面声波 (SAW) 微芯片，可快速增强基于微珠的免疫测定中的荧光，从而对人类泪液样本进行灵敏且非侵入性的 DR 检测。该装置促进了免疫测定形成的颗粒混合和液滴中颗粒的浓度，从而增强了免疫荧光信号。这种可拆卸的 SAW 微芯片允许在每次使用后处理盖玻璃，从而提高叉指传感器的可重复使用性并最大限度地减少潜在的交叉污染。对 10 名志愿者（包括 DR 患者和健康个体）进行了初步临床测试。结果与 ELISA 研究结果高度一致，验证了 SAW 微芯片的高精度。这项综合研究为新型 SAW 微芯片在糖尿病患者早期检测 DR 中的潜在应用提供了重要见解。通过利用泪液中发现的蛋白质生物标志物，该设备促进了无创、快速和灵敏的检测，有可能彻底改变 DR 诊断，并通过及时干预和管理这种威胁视力的疾病来改善患者的治疗结果。