Comparison of Two Commercially Available Fentanyl Screening Immunoassays for Clinical Use.

The Journal of Applied Laboratory Medicine
Melissa M BudelierChristopher W Farnsworth

Abstract

Fentanyl is a synthetic opioid associated with illicit drug use and overdose deaths. The SEFRIA Immunalysis (IAL) and ARK fentanyl assays are both FDA-cleared, open channel immunoassays for fentanyl detection in urine. However, limited data are available in the literature comparing these assays. The objective of this study was to perform a direct comparison of these two fentanyl immunoassays. IAL and ARK fentanyl immunoassays were performed on a Roche Cobas e602 automated chemistry analyzer. Repeatability and total imprecision were compared by diluting fentanyl into urine at concentrations above, below, and at the manufacturers' cutoffs of 1.0 ng/mL. Cross-reactivity was assessed for norfentanyl and the fentanyl analogs acetylfentanyl, acrylfentanyl, and furanylfentanyl. Concordance was assessed in 90 patient samples using liquid chromatography-tandem mass spectrometry (LC-MS/MS) as the gold standard. Repeatability varied from 11.4%-17.8% on the IAL assay and 2.8%-5.5% on the ARK assay. Total imprecision was 18.9%-40.7% on the IAL assay and 2.9%-6.4% on the ARK assay. Both assays cross-reacted with acetylfentanyl (∼100%), acrylfentanyl (∼100%), and furanylfentanyl (∼20%), but only the ARK assay cross-reacted with norfentanyl (∼...Continue Reading

References

Mar 19, 2014·Future Medicinal Chemistry·Ruben S Vardanyan, Victor J Hruby
Jan 10, 2017·Drug and Alcohol Dependence·Joji Suzuki, Saria El-Haddad
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Apr 27, 2019·Frontiers in Pharmacology·Maurice WildeRenata Solimini

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Citations

Jan 9, 2021·Journal of Analytical Toxicology·Melissa M BudelierStephen M Roper
Dec 15, 2020·The Journal of Applied Laboratory Medicine·Matthew LloydChristopher W Farnsworth
Jul 16, 2021·The Journal of Applied Laboratory Medicine·Mei San TangMelissa M Budelier

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