title: Improved buprenorphine immunoassay performance after urine treatment with β-glucuronidase.
abstract: Buprenorphine (BUP), a semi-synthetic opioid analgesic, is increasingly prescribed for the treatment of chronic pain and opioid dependence. Urine immunoassay screening methods are available for monitoring BUP compliance and misuse; however, these screens may have poor sensitivity or specificity. We evaluated whether the pretreatment of urine with β-glucuronidase (BG) improves the sensitivity and overall accuracy of three BUP enzyme immunoassays when compared with liquid chromatography-tandem mass spectrometry (LC-MS-MS). Urine samples sent to our laboratories for BUP testing (n = 114) were analyzed before and after BG pretreatment by cloned enzyme donor immunoassay (CEDIA), enzyme immunoassay (EIA) and homogenous EIA (HEIA) immunoassays using a common 5 ng/mL cutoff. Total BUP and norbuprenorphine (NBUP) concentrations were measured by LC-MS-MS as the reference method. Urine BG pretreatment improved EIA, HEIA and CEDIA sensitivities from 70, 82 and 94%, respectively, to 97% for each of the three methods, when compared with LC-MS-MS. While the specificity of the EIA and HEIA remained 100% after BG pretreatment, the specificity of the CEDIA decreased from 74 to 67%. Urine pretreatment with BG is recommended to improve sensitivity of the EIA and HEIA BUP screening methods.
authors.affiliation: LabSource, Greenville, SC 29607, USA.
authors.forename: Marion L
authors.initials: ML
authors.lastname: Snyder
authors.affiliation: LabSource, Greenville, SC 29607, USA.
authors.forename: Alicia
authors.initials: A
authors.lastname: Darragh
authors.affiliation: Department of Pathology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
authors.forename: James G
authors.initials: JG
authors.lastname: Flood
authors.affiliation: LabSource, Greenville, SC 29607, USA.
authors.forename: Jenny
authors.initials: J
authors.lastname: Jones
authors.affiliation: Department of Pathology, Clinical Laboratories Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Amory 2, Boston, MA 02115, USA.
authors.forename: Kaitlin
authors.initials: K
authors.lastname: Ropar
authors.affiliation: Department of Pathology, Clinical Laboratories Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Amory 2, Boston, MA 02115, USA.
authors.forename: Petr
authors.initials: P
authors.lastname: Jarolim
authors.affiliation: Department of Pathology, Clinical Laboratories Division, Brigham & Women's Hospital, Harvard Medical School, 75 Francis Street, Amory 2, Boston, MA 02115, USA semelanson@partners.org.
authors.forename: Stacy E F
authors.initials: SE
authors.lastname: Melanson
mesh_terms: D000701:Analgesics, Opioid / Q000737:chemistry / Q000652:urine*; D002047:Buprenorphine / Q000737:chemistry / Q000652:urine*; D002853:Chromatography, Liquid; D059350:Chronic Pain / Q000652:urine; D016903:Drug Monitoring / Q000379:methods*; D005966:Glucuronidase / Q000737:chemistry*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D009293:Opioid-Related Disorders / Q000652:urine; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry; D014556:Urine / Q000737:chemistry
chemical_list: D000701:Analgesics, Opioid; D002047:Buprenorphine; D005966:Glucuronidase