2026-09-16T03:54:26Zhttps://gredos.usal.es/oai/request

oai:gredos.usal.es:10366/1621622025-04-30T19:32:55Zcom_10366_4001com_10366_3947com_10366_3946com_10366_3823col_10366_4002

Peña Lorenzo, Diego Rebollo Díaz, Noemí Sanchez Hernández, José Germán Zarzuelo Castañeda, Aránzazu 2025-01-21T11:30:06Z 2025-01-21T11:30:06Z 2021 2099-09-09 0004-5632 http://hdl.handle.net/10366/162162 10.1177/00045632211041887 1758-1001 Therapeutic drug monitoring (TDM) of voriconazole is recommended for personalizing doses. The objective of this study was to compare the enzyme immunoassay developed by ARKTM Diagnostics Inc. for the quantification of voriconazole adapted to the Architect C4000 autoanalyzer (Abbott®) with ultra-performance liquid chromatography using ultraviolet detector (UPLC-UV) method. Materials and Methods: Linearity, precision and accuracy of both methods were validated according to the Food and Drug Administration (FDA) and European Medicines Agency guidelines. The limit of quantification (LOQ) of the UPLC-UV method was determined experimentally. Both methods were applied to the analysis of 62 samples from patients. Correlation was evaluated by Passing-Bablok analysis and the concordance by the Bland–Altman method. Dosage recommendations were generated; the discordances according to the technique were evaluated. Results: All validation parameters determined for UPLC-UV met the criteria set out and LOQ of 0.1 μg/mL was established. However, when the enzyme immunoassay was used to determine concentrations ≤1 μg/ml, CVs were >20%. A linear correlation between both methods was found. However, an overestimation of immunoassay (systematic error of 0.39 μg/mL) was detected. In 11.3% of the samples, the differences in concentrations when they were determined by different techniques would imply a different therapeutic regime. These samples had concentrations close to 1 μg/mL. Conclusion: Although both techniques can be used for TDM of voriconazole, when a value close to the lower limit of the therapeutic range is determined by the ARKTM immunoassay, it would be better to verify the result by a non-automated technique to avoid possible underdosing. eng Attribution-NonCommercial-NoDerivatives 4.0 Internacional http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/embargoedAccess Voriconazole Monitoring Immunoassay UPLC 2301 Química Analítica 3201 Ciencias Clínicas métodos analíticos Comparison of ultra-performance liquid chromatography and ARK immunoassay for therapeutic drug monitoring of voriconazole info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion https://doi.org/10.1177/00045632211041887 Annals of Clinical Biochemistry: International Journal of Laboratory Medicine 58 6 657 660