ArticleJournal of analytical toxicology2025
Immunalysis tapentadol assay reformulation resolves tramadol interference.
Article in Journal of analytical toxicology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
This study evaluated the performance of the Immunalysis Tapentadol 343 Urine Enzyme Immunoassay (EIA) screening kit, focusing on the prevalence of false-positive results due to cross-reactivity with tramadol. Tapentadol is a dual-action analgesic, modulating μ-opioid receptors and inhibiting norepinephrine reuptake, while tramadol, a structurally related compound, is a weak μ-opioid receptor agonist and norepinephrine/serotonin reuptake inhibitor. Cross-reactivity between these compounds can complicate urine drug screening results for adherence monitoring in chronic pain management. A total of 28 samples initially produced false-positive results for tapentadol BNl using the Immunalysis Tapentadol 343 Urine EIA screening kit. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to confirm the absence of tapentadol. Of the false-positive samples, 61% contained tramadol at concentrations below the manufacturer-reported cross-reactivity threshold of 60 000 ng/mL, indicating assay limitations in specificity. To address this issue, a newly reformulated Immunalysis Tapentadol 343UR Urine HEIA kit was evaluated for tramadol cross-reactivity. Upon retesting the 28 false-positive samples with the reformulated kit, no false positives were detected, with results consistent with LC-MS/MS confirmation. The rate of false-positive tapentadol screens in urine has substantially reduced since the implementation of the new tapentadol kit in routine testing. These findings demonstrate the importance of assay verification to assess cross-reactivity, particularly for structurally related compounds. The reformulated Immunalysis Tapentadol 343UR kit shows improved specificity, reducing false-positive rates and enhancing the accuracy of tapentadol detection in clinical and forensic toxicology applications.
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