Rapid and Sensitive Detection of Fentanyl and Its Analogs by a Novel Chemiluminescence Immunoassay.

Autor:	Zhao JY; ATGC Inc., King of Prussia, PA, United States., Uddin M; Instanosis Inc., King of Prussia, PA, United States., Unsihuay D; Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA, United States., Butler W; Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA, United States., Xia TW; Instanosis Inc., King of Prussia, PA, United States., Xu JZ; ATGC Inc., King of Prussia, PA, United States., Wang S; ATGC Inc., King of Prussia, PA, United States., Sheng X; Instanosis Inc., King of Prussia, PA, United States., Jannetto PJ; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, United States., Wang P; Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA, United States., Xia X; ATGC Inc., King of Prussia, PA, United States.; Instanosis Inc., King of Prussia, PA, United States.
Jazyk:	angličtina
Zdroj:	Clinical chemistry [Clin Chem] 2024 Jul 05; Vol. 70 (7), pp. 978-986.
DOI:	10.1093/clinchem/hvae071
Abstrakt:	Background: Abuse of fentanyl and its analogs is a major contributor to the opioid overdose epidemic in the United States, but detecting and quantifying trace amounts of such drugs remains a challenge without resorting to sophisticated mass spectrometry-based methods. Methods: A sensitive immunoassay with a sub-picogram limit of detection for fentanyl and a wide range of fentanyl analogs has been developed, using a novel high-affinity antibody fused with NanoLuc, a small-size luciferase that can emit strong and stable luminescence. When used with human urine samples, the assay has a sub-picogram limit of detection for fentanyl, with results fully concordant with LC-MS. Results: When applied to clinical samples, the novel chemiluminescence immunoassay can detect low positive fentanyl missed by routine screening immunoassays, with a limit of detection of 0.8 pg/mL in human urine. When applied to environmental samples, the assay can detect levels as low as 0.25 pg fentanyl per inch2 of environment surface. Assay turnaround time is less than 1 h, with inexpensive equipment and the potential for high-throughput automation or in-field screening. Conclusions: We have established a novel assay that may have broad applications in clinical, environmental, occupational, and forensic scenarios for detection of trace amounts of fentanyl and its analogs. (© Association for Diagnostics & Laboratory Medicine 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
Databáze:	MEDLINE
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