Comparison of four immunoassays to an HPLC method for the therapeutic drug monitoring of methotrexate: Influence of the hydroxylated metabolite levels and impact on clinical threshold
| Autor: | Anne-Marie Dupuy, Anne-Sophie Bargnoux, Olivier Mathieu, Jean-Paul Cristol, Juliette Descoeur |
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| Přispěvatelé: | Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier) |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Metabolite
[SDV]Life Sciences [q-bio] Pharmacology 030226 pharmacology & pharmacy Nephrotoxicity assays comparison 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Therapeutic index Fluorescence Polarization Immunoassay medicine Humans clinical thresholds Pharmacology (medical) Hplc method Chromatography High Pressure Liquid Immunoassay medicine.diagnostic_test business.industry Therapeutic Drug Monitoring Methotrexate Oncology chemistry Therapeutic drug monitoring 030220 oncology & carcinogenesis Drug Monitoring business medicine.drug |
| Zdroj: | Journal of Oncology Pharmacy Practice Journal of Oncology Pharmacy Practice, SAGE Publications, 2021, pp.1078155220983407. ⟨10.1177/1078155220983407⟩ |
| ISSN: | 1078-1552 |
| Popis: | Objectives Methotrexate requires therapeutic drug monitoring in oncology because of narrow therapeutic index, especially the metabolite 7-hydroxymethotrexate exhibits nephrotoxicity. The goal of this study was to evaluate different assays and their impact on clinical decisions. Methods Following routine measurement with Abbott TDxFLx® assay (MTX-TDX), 62 samples were analysed on Architect®i1000 (MTX-ARCHI), Xpand® (ARK/XPND), Indiko® (ARK/INDI), and HPLC (MTX-HPLC) as the reference method. The influence of 7-hydroxymethotrexate was explored on ARK reagent to document the cause of the observed bias. ROC curves were built to study the impact of the method on the discharge thresholds for the patients at three levels. Results Total imprecision was below 2.60% for the methotrexate-ARCHI and close to 10% for both ARK assays for plasma pools. The correlation coefficients were 0.93, 0.93, 0.89 and 0.95, the Bland–Altman difference plot revealed a bias of 0.075, 0.037, 0.049 and –0.002, and the number of results exceeding the TE criteria of 0.1 µM was 17 (27%), 13 (21%), 15 (24%) and 15 (24%) for MTX-TDX, ARK/INDI, ARK/XPND and MTX-ARCHI, respectively. Cross reactivity with 7-hydroxymethotrexate was between 1 and 9%. Overestimation of methotrexate concentration was between –4% and +32%. The most robust clinical level was found to be the highest level (0.2 µM) with ROC curves. Conclusions The authors found the best results for imprecision with chemiluminescent microparticle immunoassay method on methotrexate-ARCHI, with bias below to the RICOS recommendations and best correlation to the reference method. Impact on the threshold values for clinical decision need to be clearly exposed to clinicians. |
| Databáze: | OpenAIRE |
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