Evaluating the performance of the Roche FEN2 fentanyl immunoassay and its clinical implementation: The role of LDT-based mass spectrometry testing

Menlyadiev, Marlen; Suhandynata, Raymond T.; Lund, Kyle; Kelner, Michael J.; Fitzgerald, Robert L.

doi:10.1016/j.jmsacl.2023.02.009

Cited by 6 publications

(1 citation statement)

References 20 publications

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“…Traditional gas and liquid chromatography mass spectrometry (GC-MS and LC-MS) require expensive instrumentation, relatively large sample volume and extensive sample pretreatment, resulting in the reduction in the overall assay throughput [10][11][12]. On the other hand, homogenous immunoassays [13] or lateral flow assays (LFA) [14] can easily detect fentanyl and its analogs from a few drops of human samples, have medium to high throughput, and are relatively inexpensive [15]. However, there is still a gap in limit of detection (LOD) between immunoassays and the gold-standard mass spectrometry methods, which could detect sub-nanogram to picogram per mL levels of fentanyl analogs from urine samples [10].…”

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confidence: 99%

Rapid and Highly Sensitive Detection of Fentanyl and its Analogs by a Novel Chemiluminescence Immunoassay

Zhao,

Uddin,

Unsihuay

et al. 2023

Preprint

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A highly sensitive immunoassay with 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 applied to unaltered clinical human urine samples, the assay has sub-picogram limit of detection for fentanyl, with results fully concordant with gold standard liquid chromatography-mass spectrometry. When applied to environmental samples, the assay can detect as low as 0.25 pg fentanyl per inch2environment surface. Assay turn-around-time is less than 1 hour, with inexpensive equipment needed and potential for high throughput automation or in-field screening. This novel assay has broad potential applications in clinical, environmental, occupational and forensic scenarios by detecting trace amount of fentanyl and its analogs to keep frontline workers safe.

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mentioning

confidence: 99%

Rapid and Highly Sensitive Detection of Fentanyl and its Analogs by a Novel Chemiluminescence Immunoassay

Zhao,

Uddin,

Unsihuay

et al. 2023

Preprint

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Advances in fentanyl testing

Uljon

2023

Advances in Clinical Chemistry

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

Zhao,

Uddin,

Unsihuay

et al. 2024

Clinical Chemistry

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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.

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Evaluating the performance of the Roche FEN2 fentanyl immunoassay and its clinical implementation: The role of LDT-based mass spectrometry testing

Cited by 6 publications

References 20 publications

Rapid and Highly Sensitive Detection of Fentanyl and its Analogs by a Novel Chemiluminescence Immunoassay

Rapid and Highly Sensitive Detection of Fentanyl and its Analogs by a Novel Chemiluminescence Immunoassay

Advances in fentanyl testing

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

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