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Do all screening immunoassay positive buprenorphine samples need to be confirmed?
Mohamed Saleem1, Helen Martin1, Anne Tolya1
1Chemical Pathology Directorate, South Australia Pathology, Adelaide, Australia.
Annals of Clinical Biochemistry
|January 26, 2017
Summary
Opiate interference in buprenorphine immunoassay screening can cause false positives. A specific opiate concentration threshold (<2000 µg/L) indicates no false positive, avoiding unnecessary confirmatory testing and saving costs.
Area of Science:
- Clinical Chemistry
- Toxicology
- Forensic Science
Background:
- Opiate interference in the Microgenics CEDIA® Buprenorphine assay can lead to false-positive results.
- Confirmatory testing using chromatography/mass spectrometry is often required, increasing costs and turnaround time.
Purpose of the Study:
- To determine the opiate immunoassay concentration threshold below which false-positive buprenorphine results do not occur.
- To evaluate the potential cost savings by adjusting confirmatory testing protocols.
Main Methods:
- Retrospective review of patient data over three months.
- Analysis of falsely positive buprenorphine immunoassay screens compared to gas chromatography-mass spectrometry results.
- Evaluation of opiate immunoassay concentrations in relation to buprenorphine immunoassay results.
Main Results:
- Opiate concentrations below 2000 µg/L in the CEDIA® immunoassay did not cause false-positive buprenorphine results.
- Implementing a more conservative cut-off (<1500 µg/L) for confirmatory testing is estimated to save AU$17,810 annually.
- Clinical care was not compromised by the adjusted testing protocol.
Conclusions:
- Samples with a CEDIA® opiate immunoassay result below 2000 µg/L and a positive CEDIA® buprenorphine immunoassay screen do not require confirmatory buprenorphine testing.
- This finding allows for optimized laboratory workflows and significant cost reductions in drug testing.
