A Portable Colorimetric Biosensor Platform for Urinary Colorectal Cancer Biomarker Testing in Low-Resource Settings

Vollständiger Abstract

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Early detection of colorectal cancer (CRC) is challenging in low-resource settings because access to colonoscopy and centralized laboratory testing is limited. Urine-based metabolite biomarkers offer a non-invasive alternative for CRC triage, but translating a laboratory assay into a point-of-care (PoC) system requires standardized fluid handling, operator-independent timing, field-compatible reagents, and quantitative calibration. Here, we present a low-cost, semi-automated PoC platform integrating a validated, sequential, three-metabolite CRC-biomarker assay with robotic fluid handling, a motorized chromatographic module, an optical reader, Bluetooth electronics, and tablet-guided control. The platform measures urinary diacetylspermine and hippuric acid, with creatinine serving as a normalization reference, and reports absolute quantitative concentrations. Automated dilution, tube positioning, timed incubation, controlled column elution, and software-guided transfer reduce operator-dependent variation. Using pooled urine samples spiked at clinically relevant concentrations, the creatinine assay showed a strong quadratic response (0–50 mM, R2 = 0.998), as did the diacetylspermine assay (0–4 μM, R2 = 0.979), while the hippuric acid assay showed a linear response of R2 = 0.989. The RGB sensor tracked the concentration-dependent trend observed with a laboratory microplate reader (R2 = 0.968–0.999). Reagents reformulated as lyophilized or pre-weighed, vacuum-sealed kits withstood accelerated heat and humidity (45 °C/70% RH) testing and international shipping to the pilot site very well. At approximately USD 490 for the complete instrument (including tablet) and roughly USD 7.65 in consumables per screening test, the platform offers a practical, quantitative, and portable route for decentralized CRC screening.