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    This study introduces a paper-based assay for high-sensitivity cardiac troponin I (cTnI) detection at the point-of-care. The innovative approach offers accurate, rapid, and cost-effective biomarker quantification, improving diagnostic accessibility.

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    Area of Science:

    • Biomedical Engineering
    • Analytical Chemistry
    • Diagnostics

    Background:

    • Point-of-care testing (POCT) integration necessitates enhanced assay sensitivity and precision.
    • Current POCT often falls short of laboratory standards for critical biomarker measurements.

    Purpose of the Study:

    • To develop and validate a novel, cost-effective, paper-based high-sensitivity vertical flow assay (hs-VFA) for quantitative cardiac troponin I (cTnI) measurement.
    • To demonstrate how amplified biosensing, imaging, and deep learning can improve POCT performance.

    Main Methods:

    • Development of a colorimetric paper-based sensor coupled with a portable reader utilizing time-lapse imaging.
    • Implementation of computational algorithms for digital assay validation and outlier detection.
    • Utilized gold ion amplification chemistry for enhanced sensitivity.

    Main Results:

    • Achieved a low detection limit of 0.2 pg/mL for cTnI with high precision (<7% CV) and a broad dynamic range (6 orders of magnitude).
    • Enabled accurate cTnI quantification from small serum volumes (50 μL) within 15 minutes.
    • Demonstrated strong correlation with benchtop analyzers in blinded patient sample testing.

    Conclusions:

    • The nanoparticle amplification-based computational hs-VFA platform offers a cost-effective, democratized solution for high-sensitivity POCT.
    • This technology meets clinical requirements and provides a viable alternative to traditional laboratory-based biomarker testing.