Development and GC-MS validation of a highly sensitive recombinant G6PDH-based homogeneous immunoassay for the detection of buprenorphine and norbuprenorphine in urine

J Anal Toxicol. 2007 Sep;31(7):377-82. doi: 10.1093/jat/31.7.377.

Abstract

Buprenorphine is now increasingly prescribed as an alternative to methadone for the treatment of heroin addiction. Because of its potency (dosage usages from 0.2 mg to 8 mg), the drug concentrations in body fluids are normally very low. Here, we report the first recombinant glucose-6-phosphate dehydrogenase (G6PDH)-based homogeneous immunoassay (EMIT-type assay) for free buprenorphine and free norbuprenorphine in urine. The antibody used in this assay cross-reacts nearly identically with buprenorphine and norbuprenorphine and, at the same time, has less than 1% cross-reactivity with a wide range of commonly prescribed opiates, particularly those structurally related compounds such as morphine, codeine, and dihydrocodeine. More importantly, this assay has a low detection limit of 1 ng/mL for buprenorphine or norbuprenorphine. Further evaluation of this technique using gas chromatography-mass spectrometry (GC-MS) of authentic urine samples demonstrated that the accuracy of the assay is greater than 95%. Because this assay is designed to measure the free drugs in urine, it resulted in simplification for GC-MS or liquid chromatography-MS confirmation methods that did not require urine hydrolysis before solid-phase or liquid-liquid extraction.

Publication types

  • Validation Study

MeSH terms

  • Analgesics, Opioid / therapeutic use
  • Analgesics, Opioid / urine*
  • Buprenorphine / analogs & derivatives*
  • Buprenorphine / therapeutic use
  • Buprenorphine / urine*
  • Cross Reactions
  • Enzyme Multiplied Immunoassay Technique
  • Gas Chromatography-Mass Spectrometry / methods
  • Glucosephosphate Dehydrogenase*
  • Heroin Dependence / drug therapy
  • Humans
  • Recombinant Proteins
  • Reproducibility of Results
  • Substance Abuse Detection / methods

Substances

  • Analgesics, Opioid
  • Recombinant Proteins
  • Buprenorphine
  • norbuprenorphine
  • Glucosephosphate Dehydrogenase