Comparison Between DRI Fentanyl II and LZI Fentanyl Enzyme Immunoassays
Rejwi Acharya Dahal (1), Jennifer Beckman (1), Elizabeth Mast (2), Michelle Zimmerman (1) (1) Indiana University School of Medicine, Indianapolis, IN (2) Indiana University Health, Indianapolis, IN
Rejwi Dahal, PhD (Presenter) Indiana University School of Medicine
Presenter Bio: Rejwi Dahal is a clinical assistant professor in the department of Pathology and Laboratory Medicine at Indiana University School of Medicine. Her research interests include development of analytical methods for detecting small molecules, in diverse biological matrices using advanced mass spectrometry techniques, which can be translated to patient care. She is also passionate about creating diagnostics tests tailored for at-home sample collection, particularly using dried blood spot technology, to enhance healthcare accessibility for patients in remote and underserved settings.
Relevant Financial Disclosures
(within past 24 months, reported on Feb 04, 2025)
No relevant financial relationship(s) to disclose.
Abstract
Introduction: Urine drugs of abuse panel often does not include Fentanyl at many institutions because there are not many options for FDA-cleared assays. DRI Fentanyl II has a cutoff of 1.0 ng/mL with only 7% cross reactivity towards norfentanyl at the cutoff while LZI fentanyl immunoassay is targeted towards norfentanyl with the cutoff of 5 ng/mL.
Objective: The purpose of this study was to compare clinical utility of DRI Fentanyl II and LZI Fentanyl enzyme immunoassays.
Methods: 806 urine samples were screened by DRI Fentanyl II and LZI Fentanyl immunoassays. 183 random fentanyl positive and negative samples were further analyzed by LC-MS/MS for presence of absence of fentanyl, norfentanyl, and 4ANPP. Furthermore, 4ANPP positive samples were sent to a reference laboratory for further analyses to determine if any other fentanyl analogs are present in the samples.
Results: Positive agreement and negative agreement between the two methods were 96.9% and 97.6%, respectively. Cohen’s Kappa value was 89% (84.2 %to 93.7%). There were 3 samples that were screened positive by DRI II and negative by LZI, while 17 samples were screened positive by LZI and negative by DRI II.
Conclusion: Both assays provide similar clinical utility thus, either can be adopted and incorporated into urine drugs of abuse panel.
= Discovery stage. (16.60%, 2024)
= Translation stage. (37.02%, 2024)
= Clinically available. (46.38%, 2024)
