Stability and Analytical Characterization of Voriconazole as Measured by Immunoassay.
J Appl Lab Med
; 9(3): 565-572, 2024 May 02.
Article
en En
| MEDLINE
| ID: mdl-38366039
ABSTRACT
BACKGROUND:
Voriconazole is a broad-spectrum triazole antifungal agent recommended for invasive fungal diseases, including invasive aspergillosis. Therapeutic drug monitoring via voriconazole target trough concentration is important to ensure efficacy while preventing toxicity. Our aim was to determine the stability of voriconazole as adapted and measured by an immunoassay.METHODS:
Plasma from patient samples (n = 45) evaluated by a liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was compared against an ARK immunoassay method, adapted and optimized on the Abbott Alinity c analyzer. Stability of voriconazole and analytical performance of ARK immunoassay was assessed, including functional sensitivity, limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ), linearity, and precision.RESULTS:
ARK voriconazole immunoassay was highly correlated (Pearson R = 0.988) to the LC-MS/MS method, with an average bias of 0.09â mg/L (2%). CV at LoQ of 0.5â mg/L was 3.7% while the functional sensitivity was established at 0.05â mg/L. Overall imprecision with liquid quality control material obtained from ARK was 5.0%, 6.3%, and 5.9% at 1â mg/L, 5â mg/L, and 10â mg/L, respectively. Limit of blank and LoD were 0.02â mg/L and 0.05â mg/L, respectively. Voriconazole in lithium heparin plasma separator tube declines over time, with a decrease that is more evident near or above toxic concentrations.CONCLUSION:
Voriconazole collected in gel separation tubes declines over time, possibly due to absorptive properties. Voriconazole measurements by immunoassay and LC-MS/MS demonstrated acceptable comparability with sufficient level of sensitivity and precision.
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Banco de datos:
MEDLINE
Asunto principal:
Monitoreo de Drogas
/
Espectrometría de Masas en Tándem
/
Voriconazol
/
Antifúngicos
Límite:
Humans
Idioma:
En
Año:
2024
Tipo del documento:
Article