title: A new automated urine fentanyl immunoassay: technical performance and clinical utility for monitoring fentanyl compliance.
abstract: BACKGROUND
  Opiate and other drugs of abuse screening assays have been available for many years, and successfully utilized for monitoring patient medication compliance and for detecting misuse. However, immunoassays designed to rapidly detect the highly potent synthetic opioid, fentanyl, have not been available.
  
  
  METHODS
  We evaluated a new fentanyl homogeneous enzyme immunoassay (HEIA) (Immunalysis Corporation) for its ability to accurately detect fentanyl in 307 urine samples from patients prescribed chronic opioid therapy. Samples were screened by HEIA and confirmed by LC-MS/MS and ELISA for diagnostic comparison. HEIA precision and interference studies were performed.
  
  
  RESULTS
  HEIA diagnostic sensitivity, specificity and accuracy were 97%, 99%, and 99%, respectively, in comparison with LC-MS/MS and ELISA. HEIA detected 37 of the 38 LC-MS/MS positive samples identified in our initial evaluation, including some that contained very low levels of fentanyl, <1 ng/ml (<3 fmol/l). HEIA showed minimal cross-reactivity with other opioid analgesics and commonly encountered drugs. Interferences by common urine contaminants were negligible, but we observed considerable signal suppression in acidic samples (pH<4.0).
  
  
  CONCLUSIONS
  The HEIA urine fentanyl assay allows for rapid and accurate fentanyl detection, illustrating its utility in monitoring fentanyl compliance and abuse.
authors.affiliation: Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.
authors.forename: Marion L
authors.initials: ML
authors.lastname: Snyder
authors.forename: Petr
authors.initials: P
authors.lastname: Jarolim
authors.forename: Stacy E F
authors.initials: SE
authors.lastname: Melanson
mesh_terms: D000701:Analgesics, Opioid / Q000627:therapeutic use / Q000652:urine; D001331:Automation; D059350:Chronic Pain / Q000188:drug therapy / Q000652:urine; D011307:Drug Prescriptions; D005283:Fentanyl / Q000627:therapeutic use / Q000652:urine*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D016482:Urinalysis / Q000379:methods*; D016903:Drug Monitoring
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl