Abstract

Handy and disposable point-of-care diagnostics facilitate the early screening of severe diseases in resource-limited areas. To address urgent needs in inconvenient sites, a simple colorimetric diagnostic device equipped with a capillary tube with porous hydrogel and immunocomplex particles was developed for the rapid detection of biomarkers (16 min). In this device, probe particles attach to capture particles (dp = 40 µm) and form sandwiched immunocomplexes in the presence of target biomarkers, and a red color progressively emerges when the sandwiched immunocomplex particles are blocked by the porous hydrogel embedded inside the glass capillary. Colorimetric aggregation was recorded using a smartphone and analyzed with imaging software. The limit of detection reached 1 ng/mL and showed a maximum of 79% accuracy compared with that obtained through a conventional spectrophotometric technique. The level of a diabetic retinopathy (DR) biomarker, lipocalin-1 (LCN-1), was measured in 1 µL of a human tear sample and used in testing the practicability of the proposed device. All healthy subjects showed lower intensity levels than the other diabetic counterparts (proliferative DR or nonproliferative DR patients), implying the potential of this device in clinical applications. Overall, the diagnostic device facilitates point-of-care-testing and provides a low-cost (~1 USD), compact, and reliable tool for early diagnosis in resource-limited areas.

Highlights

  • Epidemics have been threatening public health for centuries

  • The consequences impact healthcare systems, especially in resource-limited areas [4]. To deal with these challenges, microfluidic technology has evolved since its advent in the 1990s

  • Given the popularity of point-of-care testing (POCT) and smartphones in modern times, we proposed an integrated diagnostic platform equipped with a modified capillary-based device, a sandwiched immunocomplex, and a portable detection system for the rapid detection (16 min) of biomarkers in early disease diagnosis or low-abundance analytes (1 pg/mL) (Figure 1)

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Summary

Introduction

Epidemics have been threatening public health for centuries. The battle has become increasingly fierce recently as the highly contagious disease, COVID-19, broke out in early 2020 and rapidly spread worldwide, raising an unprecedented crisis [1,2]. Early diagnosis is an effective measure for containing mass transmission, heavy dependence on high-end instruments forms a barrier to facile realization [3]. The consequences impact healthcare systems, especially in resource-limited areas [4]. To deal with these challenges, microfluidic technology has evolved since its advent in the 1990s. It is a research frontier and a possible alternative for sophisticated instruments. This technology has demonstrated the feasibility of device miniaturization and the development of new art in the

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