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

Drug Alcohol Depend. 2022 Nov 1:240:109610. doi: 10.1016/j.drugalcdep.2022.109610. Epub 2022 Aug 31.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Drug testing; Harm reduction; Opioids; Overdose; Substance use.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Analgesics, Opioid / analysis
  • Chromatography, Liquid
  • Cocaine*
  • Drug Overdose* / diagnosis
  • Fentanyl / analysis
  • Humans
  • Illicit Drugs*
  • Immunoassay / methods
  • Substance Abuse Detection / methods
  • Tandem Mass Spectrometry
  • United States
  • Water / analysis

Substances

  • Analgesics, Opioid
  • Fentanyl
  • Illicit Drugs
  • Cocaine
  • Water