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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.
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.