Fentanyl is a synthetic opioid agonist that is almost 50-100 times more potent than morphine, and illicit fentanyl is the fastest growing overdose substance in the United States. Rapid identification of fentanyl in suspected overdose patients is critical for prompt treatment. This invention describes an easy to use point-of-care test to rapidly identify fentanyl in patient urine or on objects to detect the illicit transportation of fentanyl.
This technology is a competitive lateral flow immunoassay test strip capable of acting as a point-of- care (POC) diagnostic to provide rapid ‘on-site’ detection of ≥1 ng/ml fentanyl in a nonlaboratory settings.
Unlike other lateral flow assays to detect fentanyl, the described invention is the first lateral flow assay with cutoff at the clinical meaningful level of 1 ng/ml. The unique characteristics of the invention enabling this level of sensitivity compared to existing assays are covered by a US provisional patent application and may be shared under a CDA.
In 112 adults that died of intravenous fentanyl overdose, the fentanyl concentrations in the urine averaged 3.9 ng/mL. Currently, commercially available point-of-care fentanyl tests fail to detect the presence of fentanyl if it is below 10 ng/ml. Sensitive fentanyl detection is essential for properly treating overdose victims, and transporting overdose patients to a hospital. The reliance on current clinical fentanyl tests significantly delays proper intervention.
- 10x greater sensitivity than current commercially available point-of-care fentanyl tests
- Fast results and easy to use
- Identification of trace amounts of fentanyl on shipments/packages to screen for the illicit transportation of fentanyl
- Can be used in the field, emergency vehicles, or emergency rooms to rapidly identify individuals with fentanyl overdose
Individual results of clinical urine samples tested using the fentanyl strip and the LC-MS/MS method. Y-axis is fentanyl equivalent concentration as determined by the LC-MS/MS method, calculated as (LC-MS/MS fentanyl + LC-MS/MS norfentanyl x 0.08).
To validate the performance of the fentanyl strip, two groups of clinical urine samples were tested using both the fentanyl strip and an LC-MS/MS method validated according to Clinical Laboratory Improvement Act (CLIA) standards. Using the LC-MS/MS as gold standard method with 1 ng/mL fentanyl or 10 ng/mL norfentanyl as cutoffs, the clinical sensitivity of the fentanyl strip is calculated to be 100% (95% confidence interval (CI) 75.8-100%), and the clinical specificity is 99.5% (95% CI 97.3-99.9%). The incidence of fentanyl/norfentanyl-positivity in this ED population is 5.5%. The positive and negative predictive values (95% CI) of the fentanyl strip test are 92.3% (66.7-98.6%) and 100% (98.2-100%) respectively.
Stage of Development:
US provisional patent application
- Co-development (this replaces collaboration or sponsored research)