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Do all screening immunoassay positive buprenorphine samples need to be confirmed?

Authors
  • Saleem, Mohamed1
  • Martin, Helen1
  • Tolya, Anne1
  • Coates, Penny1
  • 1 Chemical Pathology Directorate, South Australia Pathology, Adelaide, Australia. , (Australia)
Type
Published Article
Journal
Annals of Clinical Biochemistry International Journal of Laboratory Medicine
Publisher
SAGE Publications
Publication Date
Nov 01, 2017
Volume
54
Issue
6
Pages
707–711
Identifiers
DOI: 10.1177/0004563216688489
PMID: 28121168
Source
Medline
Keywords
License
Unknown

Abstract

Background Interference from opiates in the Microgenics CEDIA® Buprenorphine assay is known to produce false-positive buprenorphine screening immunoassay results necessitating confirmatory buprenorphine testing by chromatography/mass spectrometry methods. Method We reviewed data on falsely positive buprenorphine immunoassay screen (cut-off ≥ 5 µg/L) but negative for buprenorphine by gas chromatography mass spectrometry (cut-off ≥ 5 µg/L) and had a positive opiate immunoassay result (cut-off ≥ 300 µg/L). The results were collected over three months, and the data were evaluated to determine whether there is an opiate immunoassay screen concentration below which a false-positive buprenorphine result will not occur. Results We found that cross-reactivity in the CEDIA® buprenorphine immunoassay by opiates at concentrations <2000 µg/L will not cause a false-positive buprenorphine result. After changing our practice to not proceed with confirmatory buprenorphine gas chromatography mass spectrometry assay when the opiate screening concentration is below an even more conservative cut-off of <1500 µg/L, we estimate a potential cost-saving of AU$ 17,810 per year without compromising clinical care. Conclusion Samples with CEDIA® opiate immunoassay result <2000 µg/L and a positive CEDIA® buprenorphine immunoassay screen do not require confirmatory testing for buprenorphine.

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