Detection of Fungal Infection via Macroscopic Fluorescence of DNA/RNA using Non-Toxic SYBR-safe Dyes for a New, Accurate, Fast, Handheld, Small Blood Volume Diagnostic (SBVD) Device: InnovaBug™ - Proof of Concept*

The COVID-19 pandemic caused by the SARS-CoV-2 virus^[1], and its secondary bacterial and fungal infections ^[2-5] have created an urgent need for a new, Small Biological Sampling Volume Diagnostic (SBVD) Device, which is Handheld, Low-Cost, Fast, and Reliable. This device needs to detect new rising pathogens at the triage level -  before pathogen identification and specific tests can be developed and widely distributed. Pathogen load evaluation is needed to rapidly evaluate both the infection degree of severity and therapies effectiveness. State-of-the art infection diagnostics in Blood, Serum, Urine, Sputum and Spinal fluids use the universally accepted Colony Forming Units (CFUs) counting. This requires 10-30 mL of fluid and 24-72 hours of incubation, taking days for results, and yielding 30% false positives. Misdiagnosed infections leads to massive overuse of antibiotics costing US hospitals ~ $20 Billion/year, and causing 35,000+ US deaths/year from antibiotic resistant infections^[10-11]. InnovaBug™ aims to detect pathogens and count pathogen loads via SYBR-safe fluorescent dyes binding to nucleic acid pairs in DNA/RNA helices. Recently, macroscopic bacterial detection was tested successfully using 0.3 mL drops of SYBR dyes on 0.3 mL calibrated pathogen solutions, via the first proof-of-concept studies to develop InnovaBug™ ^[6-9] . The present work uses this approach to detect fungal infections by Macroscopic Epi-Fluorescence^[6-9,12] via SYBR dyes on fungal colonies for InnovaBug™.