A Rapid, Sensitive and Instrument-free Oral Fluid Fentanyl Test

Project Summary Fentanyl is a major contributor to the Opioid Epidemic, causing increasing morbidity and mortality. Rapid identification of fentanyl in different body fluid samples enables prompt and appropriate administration of naloxone, and the appropriate level of clinical care. The clinical and public health urgency for the wide availability of rapid fentanyl tests is recognized in the clinical and scientific field. We have successfully developed a rapid fentanyl urine test, which was designated as an FDA Breakthrough Device in 2023 and is pending FDA 510(k) clearance for over-the-counter (OTC) use. Compared to urine, oral fluid is easy to obtain from overdosed individuals at home or in the emergency transportation vehicles for rapid fentanyl identification. In the drug compliance or workplace drug testing settings, oral fluid collection has the advantage of being directly observable and tamper resistant. Although there is good correlation between urine and oral fluid fentanyl concentrations, fentanyl concentration in oral fluid is significantly lower. Towards the goal of developing a highly sensitive oral fluid fentanyl rapid test, Instanosis was awarded a NIDA Phase I SBIR grant and Supplement to develop a high affinity anti-fentanyl antibody and oral fluid fentanyl test prototype. Having successfully completed Phase I and Supplement, in this Phase II project, we propose to further integrate prototype components and finalize the oral fluid fentanyl test design and conduct verification and validation studies to prepare for FDA submission. The goal is to develop the first FDA-cleared oral fluid fentanyl rapid test that has a diagnostic cutoff at <1 ng/mL fentanyl (>10x more sensitive than commercially available forensic test cup), readout time 5 min (4x less time than commercially available forensic test cup), and required oral fluid 100 µL (10x less volume than commercially available forensic test cup).