Evaluation of Buprenorphine CEDIA Assay versus GC-MS and ELISA using Urine Samples from Patients in Substitution Treatment

Abstract

As buprenorphine becomes more clinically used in heroin substitution treatment, there is an increasing need for methods suitable for high-volume screening. In this study, a new immunochemical test based on CEDIA technology was evaluated for the use in clinical urine drug testing. The method was compared with an existing ELISA method and a gas chromatography-mass spectrometry (GC-MS) method on urine specimens from patients in heroin substitution treatment. The precision of the CEDIA assay was < 9% both within- and between-day at levels at and above the cutoff limit of 5 microg/L. The concordance in qualitative results with an existing ELISA method was 96.8%. The CEDIA measuring range was extended by diluting urine samples 100-fold with saline, and the results agreed well (slope of regression line was 1.09, r(2) = 0.968) with GC-MS. The sensitivity of CEDIA in detecting authentic specimen containing buprenorphine at levels >or= 5 microg/L was 99.5%. Cross-reactivity causing false-positive response was discovered in patients receiving prescribed dihydrocodeine. The urine concentration of total buprenorphine in urine from patients prescribed daily doses between 0.2 and 24 mg ranged from 0.5 to 2900 microg/L. The concentration of the metabolite norbuprenorphine was usually higher, and the median ratio of buprenorphine to norbuprenorphine was 0.23 (95% were below 1). We conclude that the CEDIA assay is suitable for application in high-volume screening of buprenorphine for urine drug testing.

Laboratory Testing for Prescription Opioids

“…Detection of these opioid drugs therefore requires entirely separate immunoassays that are specific for these compounds [27][28][29][30] or methods capable of their detection and specific identification such as liquid chromatography-tandem mass spectrometry (LC-MS/MS) [20,[31][32][33].…”

“…It is also not detected by morphine-specific opiate immunoassay screening tests (see Table 1). Immunoassay [30], GC-MS [75][76][77], and LC-MS [78][79][80][81][82] methods that are specific for buprenorphine are available and should be used when detection of this drug is required.…”

La spectrométrie de masse et ses principales applications en biologie médicale

“…• toxiques [40][41][42] : métaux (jusqu'à 34 éléments), cyanures ; • dopage : détection et identification de stéroïdes anabolisants [43], nandrolone et métabolites (norandrostérone et noréthio-cholanolone) ; • stupéfiants et soumission chimique [44] : opiacés [45,46], cocaïniques [47], buprénorphine et norbuprénorphine [48], cannabis [49], LSD [50], dérivés de l'ecstazy [51], GHB [52], kétamine [53]. Remarque : La spectrométrie de masse est, bien sûr, applicable en biologie vété-rinaire ; elle est très présente dans le domaine de l'agroalimentaire et de la protection de l'environnement : • agroalimentaire : dioxine dans les poissons contaminés [54], PCB dans les matières grasses, le lait et les oeufs, [57], explosifs dans les aéroports et les gares [58].…”

Le dépistage immunochimique des médicaments substitutifs de l'héroïne et autres opioïdes

“…Les urines, bien entendu, où les seuils de positivité utilisées varient entre 0,5 ng/mL [29,31], 2 ng/mL [30] et 5 ng/mL [32][33][34]. Toutefois, l'utilisation d'un seuil trop bas, comme 0,5 ng/mL, s'accompagne d'un certain nombre de faux positifs, plus de 26,5 % dans l'étude de Cirimele et coll.…”