Validation of a lateral flow chromatographic immunoassay for the detection of fentanyl in drug samples

Drug overdose deaths remain the primary cause of unintentional injuries in the United States. We examined the validity of a fentanyl test strip (FTS) in detecting fentanyl and its related analogs in water-based illicit drug solutions.Illicit drugs obtained from law enforcement (N = 343) were tested using a lateral flow chromatographic immunoassay FTS (BTNX Rapid Response) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) at a clinical chemistry laboratory in Baltimore, Maryland.The FTS assay detected fentanyl at 200 ng/ml in water, and 13 additional fentanyl analogs, but failed to detect carfentanil and furanyl fentanyl at or below 1000 ng/ml. Overall sensitivity and specificity for detecting fentanyls was 98.5 % and 89.2 %; and the false negative and positive rate was 1.5 % and 10.9 %. False negatives (n = 2) occurred in fentanyl and a fentanyl precursor. False positives (n = 23) occurred in the presence of other illicit drugs and compounds (56.5 %) or when fentanyls were present below 40 ng/ml (43.5 %). False positive/negative rates remained low when testing cocaine and prescription opioid (PO) samples.FTS is a valid drug checking tool, however, rapid immunoassays and other drug checking instruments that can detect a wider range of fentanyl analogs including carfentanil need to be prioritized to minimize accidental exposure to the full spectrum of fentanyls.