B-286 Fentanyl immunoassays on the line: a comparative study among three different assays for fentanyl detection
Notice bibliographique
Résumé
Abstract Background Fentanyl is a synthetic opioid drug that is widely used as a potent analgesic and anesthetic. Due to the recent fentanyl epidemic and spike in overdose death, fentanyl screening in urine has become more critical. The most common screening methodology for fentanyl is immunoassay and choosing the right immunoassay is essential to avoid consequences from false negative or false positive results. The commonly used FDA approved fentanyl immunoassays available are Immunalysis, ARK II from Ark Diagnostics, and FEN2 by Lin-Zhi (Roche). In this study we aimed to compare their performance with Liquid Chromatography Mass Spectrophotometry (LC-MS/MS) confirmatory assay and evaluated their specificity and sensitivity rates. Furthermore, we investigated the presence of fentanyl analogs which could result in a positive result in immunoassays but could be missed in a confirmatory assay that only detects fentanyl or the primary metabolite norfentanyl. Methods Fifty remnant patient urine samples were analyzed for fentanyl across 3 different immunoassay systems: the Immunalysis (cutoff 2ng/mL), Lin-Zhi FEN2 (cutoff 5 ng/mL), and ARK II (cutoff 1?ng/mL) and all were performed on Beckman AU5800 platforms. Samples were either analyzed right away or frozen for further analysis. All the samples were tested on a LC-MS/MS confirmatory method with a limit of detection of 0.5 ng/mL for both fentanyl and the primary metabolite norfentanyl. In addition, all samples were tested for fentanyl analogs on a second LC-MS/MS method. Those analogs include: 3-Methylfentanyl, 4-Fluorobutyrylfentanyl, 4-Fluoroisobutyrylfentanyl, Acetylfentanyl, Acetylnorfentanyl, Acrylfentanyl, Alfentanil, Butyryl fentanyl, Carfentanil, Cyclopropyl fentanyl, Despropionyl fentanyl, Furanyl fentanyl, Isobutyryl fentanyl, Methoxyacetyl fentanyl, O/P-fluorofentanyl, Sufentanil, Tetrahydrofuranyl fentanyl, Valeryl fentanyl. Results Out of 50 patient urine samples, there were 27 positive and 23 negative samples reported by LC-MS/MS. The Immunalysis assay had 5 false positive and 5 false negatives, ARK II had 0 false positives and 2 false negatives, and the Lin-Zhi FEN2 had 0 false positives and 1 false negative. The 5 false positive samples in Immunalysis assay were consistently negative in other immunoassays and LC-MS/MS confirmatory assays. The false negative results in Immunalysis assay were due to lack of assay cross reactivity for norfentanyl. The sensitivity and specificity of all the immunoassays in this study were determined against LC-MS/MS confirmatory results. Out of all 50 samples that were tested for fentanyl analogs on LC-MS/MS only 3 samples across all assays tested positive for the analog Despropionyl Fentanyl as well as fentanyl and norfentanyl. No other fentanyl analogs were detected in our samples. Conclusion Our data set indicates that ARK II and Lin-Zhi assays have a comparable performance in detection of fentanyl or norfentanyl, while Lin-Zhi shows a slightly better sensitivity. Immunalysis assay, however, demonstrates significantly lower sensitivity and specificity. The false positives in Immunalysis assay occurred near the assay’s detection cutoff. This high rate of false positive could be due to intrinsic features of this assay and potential cross reaction with other drugs/medications in the sample. Finally, our data indicates that fentanyl analogs were not the reason behind any of the false positives.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».