A New Highly Specific Buprenorphine Immunoassay for Monitoring Buprenorphine Compliance and Abuse

Melanson, Stacy E.F.; Snyder, Marion L.; Jarolím, Petr; Flood, James G.

doi:10.1093/jat/bks003

Cited by 33 publications

(26 citation statements)

References 10 publications

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“…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].…”

Section: Urine Screening For Opioidsmentioning

confidence: 99%

Laboratory Testing for Prescription Opioids

Milone

2012

J. Med. Toxicol.

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Opioid analgesic misuse has risen significantly over the past two decades, and these drugs now represent the most commonly abused class of prescription medications. They are a major cause of poisoning deaths in the USA exceeding heroin and cocaine. Laboratory testing plays a role in the detection of opioid misuse and the evaluation of patients with opioid intoxication. Laboratories use both immunoassay and chromatographic methods (e.g., liquid chromatography with mass spectrometry detection), often in combination, to yield high detection sensitivity and drug specificity. Testing methods for opioids originated in the workplace-testing arena and focused on detection of illicit heroin use. Analysis for a wide range of opioids is now required in the context of the prescription opioid epidemic. Testing methods have also been primarily based upon urine screening; however, methods for analyzing alternative samples such as saliva, sweat, and hair are available. Application of testing to monitor prescription opioid drug therapy is an increasingly important use of drug testing, and this area of testing introduces new interpretative challenges. In particular, drug metabolism may transform one clinically available opioid into another. The sensitivity of testing methods also varies considerably across the spectrum of opioid drugs. An understanding of opioid metabolism and method sensitivity towards different opioid drugs is therefore essential to effective use of these tests. Improved testing algorithms and more research into the effective use of drug testing in the clinical setting, particularly in pain medicine and substance abuse, are needed.

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Section: Urine Screening For Opioidsmentioning

confidence: 99%

Laboratory Testing for Prescription Opioids

Milone

2012

J. Med. Toxicol.

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“…For example, previous studies have demonstrated false positives with buprenorphine (7 ) and 6-AM immunoassays (Thermo Scientific, formerly Microgenics), owing to nonspecific cross-reactivity with other opioids including methadone, morphine, and tramadol. Hydroxychloroquine has also been shown to generate false-positive responses in the buprenorphine assay (8 ). Highly colored and/or concentrated urines can also be problematic for screening by immunoassays that rely on photometric readings.…”

Section: Discussionmentioning

confidence: 99%

“…Buprenorphine, its major metabolite, norbuprenorphine; 6-AM; and fentanyl and its major metabolite, norfentanyl, were all negative by LC-MS/ MS. The positive screening results for 6-AM and buprenorphine were most likely due to the presence of high levels of known interferences, morphine and hydroxychloroquine, in the patient's urine, and were false positives (8 ). The nonspecific antibody crossreactivities in the buprenorphine and 6-AM assays were likely exacerbated by the fact that the sample was highly concentrated (urine creatinine Ͼ600 mg/dL), yielding higher concentrations of interfering drugs.…”

Section: Case Resolutionmentioning

confidence: 99%

Drug Addiction or False Conviction?

Snyder¹,

Melanson

2014

Clinical Chemistry

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CASEA 25-year-old woman with a history of multiple medical problems including a distal pancreatectomy and splenectomy 6 months earlier for pancreatic mass (solid pseudopapillary tumor with negative margins), systemic lupus erythematous (SLE), 3 Crohn disease, and a history of alcohol abuse presented to her pain management physician with weakness, decreased appetite, worsening joint pain, abdominal pain, and diarrhea (five episodes per day, some visibly bloody). At presentation, her vital signs included temperature 97.1°F, blood pressure 127/89 mmHg, and heart rate 97 beats/min. Physical exam was remarkable for hyperactive bowel sounds, diffuse joint pain, and periumbilical pain at the surgical incision site described as constant and gnawing and graded 8 out of 10. She was prescribed morphine and oxycodone (as needed) for pain; hydroxychloroquine and prednisone for SLE; and mesalamine, docusate, and infliximab for Crohn disease.She was referred to her gastroenterologist for management of her gastrointestinal complaints. Her dosages of prednisone and hydroxychloroquine were maintained to control her SLE. Pulse doses of steroids and a higher dose of prednisone were considered, but the risk of infection was determined to be too great. Before refilling her morphine and oxycodone prescriptions, her physician confirmed that her previous urine drug testing results showed the presence of her prescribed medications (and related metabolites), suggesting medication compliance, as well as no unexpected drugs. The physician also performed a pill count and documented her last dose of morphine (that morning) and oxycodone (3 days before). In addition, she was asked to complete a Screener and Opioid Assessment for Patients with Pain questionnaire (1 ), designed to assess her risk of medication noncompliance and abuse. On the basis of her responses to the questionnaire, the pill count, and her previous consistent urine drug testing results, the physician felt she was at low risk for noncompliance and renewed her oxycodone and morphine prescriptions. Because her last urine drug testing was performed 5 months earlier, he requested that she also submit a new urine sample for testing.After 3 days, the physician viewed the patient's most recent urine drug testing results, at which time only results for in-house testing were available (Table 1). The patient's urine screened positive for 6-acetylmorphine (6-AM), a unique heroin metabolite, and buprenorphine. The fentanyl screen was unsatisfactory due to an interfering substance. All other screening results were negative. Adulterant testing was significant for a creatinine of Ͼ600 mg/dL in a relatively darkly colored urine. Specific opioid testing by LC-MS/MS revealed the presence of morphine (Ͼ300 000 ng/mL) and hydromorphone (472 ng/mL). Codeine, hydrocodone, oxycodone, and oxymorphone were not detected. Reflexive tests to confirm the positive 6-AM and buprenorphine and the indeterminate fentanyl were ordered but pending. On the basis of the results available at the time, the physician...

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“…Qualitative immunoassay screens (Table ) are performed on Beckman AU480 analyzer (Beckman Coulter Inc., Brea, CA, USA) using a homogenous enzyme immunoassay (EIA) (Immunalysis Corporation, Pomona, CA, USA) for fentanyl and tramadol; a Diagnostic Reagents Inc (DRI) EIA (Microgenics, now Thermo Scientific, Fremont, CA, USA) for amphetamines, barbiturates, cannabinoids, cocaine, ethanol, 3,4‐methylenedioxymethamphetamine (MDMA), and methadone; an EIA (LinZhi International, Sunnyvale, CA, USA) for 6‐AM and buprenorphine ; and a cloned enzyme donor immunoassay (Thermo Scientific) for benzodiazepines and EDDP. All methods rely on the measurement of a change in the enzymatic activity (a change in the rate of absorbance increase) after combining the patient sample with the antidrug antibody and enzyme–drug conjugate.…”

Section: Methodsmentioning

confidence: 99%