Microfluidic Platforms for Rapid Pathogen Detection

Abstract

Rapid, accurate pathogen detection at the point of care is essential for infectious disease management, antimicrobial stewardship, and pandemic preparedness. This study developed and evaluated three microfluidic diagnostic platforms - isothermal nucleic acid amplification (LAMP-on-chip), immunoassay-based lateral flow with microfluidic sample preparation (µLFA), and electrochemical impedance biosensing (EIS-chip) -- for the detection of SARS-CoV-2, influenza A/B, and Staphylococcus aureus from nasopharyngeal swab and blood samples. All three platforms were fabricated in PDMS using standard soft lithography and designed for single-use disposable cartridge format with smartphone-based readout. LAMP-on-chip achieved the highest analytical sensitivity (limit of detection 10 copies/µL for SARS-CoV-2 RNA) with time-to-result of 28 +- 3 min and clinical sensitivity of 97.8% (89/91 RT-qPCR-confirmed positives) in a 240-patient prospective clinical validation. µLFA achieved the fastest time-to-result (12 +- 2 min) with clinical sensitivity of 88.4% for SARS-CoV-2 and 94.2% for influenza A, suitable for mass screening applications. EIS-chip demonstrated the broadest multiplexing capacity (simultaneous detection of 6 targets on a single 16-electrode array) with clinical specificity of 99.2% and LOD of 100 CFU/mL for S. aureus bacteraemia detection. These findings establish LAMP-on-chip as the most sensitive near-patient molecular diagnostic, µLFA as the fastest screening tool, and EIS-chip as the optimal platform for multiplexed syndromic panel testing at the point of care.