Near real-time electrochemical platform for culture-free bacteria detection in aqueous solutions

Overview

This solution is a modified electrochemical immuno-sensing platform designed to detect and identify microorganisms in aqueous solutions in near real-time, without the need for culture-based enrichment. Conventional culture-based bacterial diagnostics require 16 to 72 hours, driven by bacterial doubling times of roughly 20 minutes, which prevents timely clinical or industrial decision-making. The proposed platform targets a time-to-result of approximately two hours while maintaining a limit of detection below 1 CFU/mL, a per-test cost under $20, and a form factor compatible with point-of-care (POC) deployment.

Technical specifications

• Detection principle: Voltage-controlled intrinsic signal amplification on an electrochemical immuno-sensing platform that enables direct detection of bacteria in the sample without culture enrichment
• Specificity: Antibody-microorganism immune interaction provides target-specific recognition
• Performance targets: Time-to-result of approximately 88 minutes for a single sample (with a goal of two hours overall), limit of detection below 1 CFU/mL, and cost per test under $20
• Sample compatibility: Tested with spiked PBS, whole human blood, and clinical blood samples
• Planned integrated prototype: Compact reader paired with disposable plates of integrated bacteria-specific screen-printed electrodes, with a multi-channel electrochemical potentiostat and supporting electronics for simultaneous multiplexed measurements
• Point-of-care design: POC-compatible architecture intended for use outside centralized laboratory settings

Technology readiness level

The underlying feasibility has been demonstrated through a published study using the current prototype for culture-free diagnosis of bacterial infections in spiked human blood. An analytical validation has been completed following the Clinical Laboratory Improvement Amendments (CLIA) format, and hospital-based testing of 70 clinical blood samples covering E. coli, K. pneumoniae, P. aeruginosa, N. gonorrhoeae, S. aureus, MRSA, and S. pneumoniae produced results comparable to commercial diagnostic technologies while delivering outcomes 18 to 20 hours sooner. A third-party validation has also been completed with 100% success. Remaining development work focuses on confirming detection of target bacteria on the current prototype, tuning platform parameters to consistently meet the two-hour time-to-result and sub-1 CFU/mL detection limit, and building a compact, multiplexed integrated prototype with disposable screen-printed electrode plates.