Quantitative Detection of Pathogens from DNA/RNA Macroscopic Fluorescence Compared to Conventional Cultures and Colony Counting to Calibrate a New, Handheld, Fast, Small Volume Blood Diagnostics Device for Infection Triage: InnovaBug™

Current medical diagnostics use bodily fluid cultures to detect infections, yet 30% of cultures yield false positives^[1-2]. Moreover, cultures require large quantities of fluid, 10-30 mL and 3-5 days of incubation ^[1-5].

False positives lead to overuse of antibiotics, costing $20 B/year in unnecessary medical treatments in the US alone^[1]. Large blood volumes in cultures lead to Hospital Acquired Anemia in 74% of hospitalized patients ^[5-6].

This work is developing a new, inexpensive, hand-held Small Volume Blood Diagnostics device, InnovaBug™, to detect infections for triage and proper therapy^[7-8].

InnovaBug™ uses only three drops (0.03-0.3 mL) of fluid to yield accurate results within +/-10% (the medical ‘gold standard').

InnovaBug™ uses a super-hydrophilic coating, with green, red, and blue nucleic acid fluorescent stains.

LactoB. A. is the initial test bacteria.

Fluorescence is measured via a cell phone camera in a small black box where the slide is inserted.

The coating disperses the drops so photons — thus fluorescing pathogens— are counted over a statistically large area ^[9].

To calibrate measurements, irradiation via three UVC LEDs is incorporated into the unit designed to achieve a kill rate of 99.9999%.

Before UVC irradiation, fluorescence is highly visible if pathogens are present.

After UVC, fluorescence decreases.

The fluorescence intensity ratio, R, compares pre- and post-UVC fluorescence and is calibrated with colony counts from conventional cultures ^[9-11].