SEP 05, 2018 8:00 AM PDT

A New Paradigm for Buprenorphine Testing

Speaker
  • Sr. Technical Specialist, Univ. of Calif. San Diego Health Center for Advanced Laboratory Medicine, Mass Spectrometry/Toxicology Laboratory
    Biography
      Judy Stone worked as a Clinical Laboratory Scientist in San Jose, CA and then obtained her doctorate in Clinical Biochemistry at the University of Toronto. Her fellowship in Clinical Chemistry was at the University of Minnesota Hospital & Clinics. She has since served as Asst. Professor and Assoc. Director of Clinical Chemistry at the University of Connecticut Health Center, as Asst. Professor and Director of the Core, Immunology and Toxicology Laboratories at the University of Massachusetts Medical Center; and worked with mass spectrometry at Specialty Laboratories, San Francisco General Hospital and Kaiser Regional Laboratories in Northern California. She is currently Senior Technical Specialist in the Clinical Mass Spectrometry Laboratory, Center for Advanced Laboratory Medicine, Univ. of Calif. San Diego Health System.

      Her research interests are in mass spectrometry method development, validation and automation for clinical toxicology and endocrinology. She was the faculty chair for the 2009 edition of the AACC Online Certificate program "Using Mass Spectrometry in the Clinical Laboratory". She teaches, with a team of colleagues, a two day short course on "Getting Started with Quantitative LC-tandem MS in the Diagnostic Laboratory" at MSACL meetings in the U.S. and Europe. She is a member of AACC and ASMS and serves as Chair, Board of Editors for the Mass Spectrometry Feature Series, Clinical Laboratory News.

    Abstract

    DATE: September 5, 2018
    TIME:  8:00AM PDT

    A New Paradigm for Buprenorphine Testing

    Buprenorphine (BUP) is a partial mu-agonist synthetic opioid, an important drug for treating opioid use disorder.  BUP is often prescribed as a sublingual co-formulation with the opioid antagonist naloxone (NXO) to deter illicit parenteral use and diversion.  Best practice recommendations include monitoring for BUP prescription compliance by testing urine for BUP and the metabolites BUP-glucuronide, norbuprenorphine (NBP) and NBP-glucuronide or by testing for total BUP and total NBP after glucuronide hydrolysis.  In this webinar we will review the pharmacokinetics of BUP, NBP and NXO and then discuss strategies for optimizing automated sample preparation with the Tecan AC Extraction PlateTM for LC-MS/MS analysis of these analytes.  Our question was – could we simplify the analysis by measuring only free BUP, NBP and NXO at sufficiently low quantitation limits such that no false negatives would occur?  If so – we could avoid the time consuming and expensive glucuronide hydrolysis step or alternatively the more labor-intensive measurement of both free and glucuronide analytes.  After validating limits of quantitation of 0.2 ng/mL (free BUP), 0.5 ng/mL (free NBP), and 5 ng/mL (free NXO) we compared results for free and total BUP, NBP and NXO in 222 patient samples.  The results of that study support monitoring for BUP compliance using positive/negative cutoffs of 0.2 and 0.5 ng/mL for free BUP and free NBP respectively.  We will review the results of the method validation, the distributions of free, total, and % free BUP, NBP and NXO concentrations in this cohort and discuss interpretation for individual samples of interest.

    Learning Objectives:

    • Diagram the metabolism of sub-lingual buprenorphine/naloxone and list the relative and range of concentrations of free and total buprenorphine, metabolites and naloxone to be expected in urine samples.
    • Describe the chemistry and process for AC plate extraction.
    • List the characteristics of a compound suitable for extraction with the AC plate and explain how pH modification of extraction and elution reagents may improve extraction recovery for weak acids/bases.

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