Therapeutic drug monitoring of voriconazole: validation of a novel ARK™ immunoassay and comparison with ultra-high performance liquid chromatography

Cattoir, Lien; Fauvarque, Grégoire; Degandt, Simon; Ghys, Timothy; Verstraete, Alain G.; Stove, Veronique

doi:10.1515/cclm-2014-0774

Cited by 6 publications

(10 citation statements)

References 27 publications

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“…Compared with the recently published study with ARK™ Voriconazole Assay, our results showed slightly better precision [26] . In the previous study with immunoassay, however, a method comparison was performed with ultra-high performance liquid chromatography method with photodiode array detection (UPLC-PDA), one of ultraviolet-detecting methods.…”

Section: Discussioncontrasting

confidence: 51%

“…The ARK™ Voriconazole Assay (ARK Diagnostics, Inc., Fremont, CA, USA) is a homogeneous enzyme immunoassay intended for the quantitative determination of voriconazole in human serum or plasma on automated clinical chemistry analyzers. To date, there is one study which have been conducted to evaluate the analytical imprecision and bias in the quantitation of voriconazole with routine clinical chemistry analyzers [26] . Thus, we confirmed the results of the first study and assessed the previously unevaluated performance of voriconazole quantitation based on an enzyme immunoassay using automated clinical chemistry analyzers in a routine clinical laboratory.…”

Section: Introductionmentioning

confidence: 99%

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Performance evaluation of enzyme immunoassay for voriconazole therapeutic drug monitoring with automated clinical chemistry analyzers

Jeon

Han

et al. 2017

Practical Laboratory Medicine

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ObjectiveVoriconazole is a triazole antifungal developed for the treatment of fungal infectious disease, and the clinical utility of its therapeutic drug monitoring has been evaluated. Recently, a new assay for analyzing the serum voriconazole concentration with an automated clinical chemistry analyzer was developed. We evaluated the performance of the new assay based on standardized protocols.MethodsThe analytical performance of the assay was evaluated according to its precision, trueness by recovery, limit of quantitation, linearity, and correlation with results from liquid chromatography-tandem mass spectrometry (LC-MS/MS). The evaluation was performed with the same protocol on two different routine chemistry analyzers. All evaluations were performed according to CLSI Guidelines EP15, EP17, EP6, and EP9 [1–4].ResultsCoefficients of variation for within-run and between-day imprecision were 3.2–5.1% and 1.5–3.0%, respectively, on the two different analyzers for pooled serum samples. The recovery rates were in the range of 95.4–102.2%. The limit of blank was 0.0049 μg/mL, and the limit of detection of the samples was 0.0266–0.0376 μg/mL. The percent recovery at three LoQ levels were 67.9–74.6% for 0.50 μg/mL, 75.5–80.2% for 0.60 μg/mL, and 89.9–96.6% for 0.70 μg/mL. A linear relationship was demonstrated between 0.5 μg/mL and 16.0 μg/mL (R2=0.9995–0.9998). The assay correlated well with LC-MS/MS results (R2=0.9739–0.9828).ConclusionsThe assay showed acceptable precision, trueness, linearity, and limit of quantification, and correlated well with LC-MS/MS. Therefore, its analytical performance is satisfactory for monitoring the drug concentration of voriconazole.

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Section: Discussioncontrasting

confidence: 51%

Section: Introductionmentioning

confidence: 99%

Performance evaluation of enzyme immunoassay for voriconazole therapeutic drug monitoring with automated clinical chemistry analyzers

Jeon

Han

et al. 2017

Practical Laboratory Medicine

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“…To our knowledge, there are only two previous studies that have made a comparison between chromatographic and EIA methods used for voriconazole determination. The first one is a validation of an ARK immunoassay method and comparison with an ultra-HPLC with photodiode array detention (UPLC) 23. In this study a linear correlation was observed between both methods, with a concordance correlation coefficient of 0.96.…”

Section: Discussionmentioning

confidence: 68%

Therapeutic drug monitoring of voriconazole: validation of a high performance liquid chromatography method and comparison with an ARK immunoassay

et al. 2020

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ObjectiveVoriconazole is an antifungal agent used in the treatment of aspergillosis and fluconazole-resistant Candida infections. Therapeutic drug monitoring (TDM) of voriconazole is recommended to optimise clinical results. The aim of this study was the development and validation of a high performance liquid chromatography (HPLC) method for measuring voriconazole in human serum, and comparison with an ARK immunoassay method.MethodsLinearity, precision, accuracy and stability of the HPLC method were validated according to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The method was applied to the analysis of 58 trough serum samples from patients treated with voriconazole, and the HPLC-UV (ultraviolet) method was compared with an ARK immunoassay. The correlation of both methods was studied by the Pearson regression coefficient and the concordance of the values was evaluated by the Bland-Altman and Passing-Bablok methods.ResultsAll validation parameters met the criteria set out in the FDA and EMA guidelines. The standard curve was linear over a concentration range of 0.25–16 µg/mL with a limit of quantification of 0.125 µg/mL. No interactions between voriconazole and other drugs was observed and voriconazole was stable after 1 month at −80°C. Comparison of the HPLC method and the enzyme immunoassay method showed a linear correlation with a systematic error of −0.61 µg/mL between both methods.ConclusionThe method developed is simple and fast and can be easily applied for routine therapeutic drug monitoring of voriconazole. The HPLC-UV method was more sensitive than the immunoassay method and there was concordance with the immunoassay. Consequently both methods could be used, considering the correlation between them.

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“…However, the small bias is likely to be permitted in clinical TDM practice. Previous studies provided the similar bias [ 7 , 8 ]. Next, 7 concentrations out of acceptable measurement error range were observed in total, where 4 (2 in the standard filter method, 2 in the dilute method) concentrations were higher in LM1010 than outsourcing, remained 3 concentrations (2 in the standard filter method, 1 in the dilute method) were higher in outsourcing than LM1010.…”

Section: Main Textmentioning

confidence: 72%

Clinical evaluation of an authorized medical equipment based on high performance liquid chromatography for measurement of serum voriconazole concentration

Oda

Uchino

Kurogi

et al. 2021

J Pharm Health Care Sci

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Background Therapeutic drug monitoring for voriconazole is recommended for its optimum pharmacotherapy. Although the feedback of the measurement result of serum voriconazole concentration by outsourcing needs a certain time (days within a 1 week), there was no medical equipment for the measurement available in clinical practice. Recently, a medical equipment based on high performance liquid chromatography, named LM1010, has been developed and authorized for clinical use. In this study, to validate the clinical performance of LM1010, we compared the measured serum voriconazole concentrations by LM1010 with those by outsourcing measurement using liquid chromatography-tandem mass spectrometry. Methods We conducted the observational study approved by the institutional review board of Kumamoto University Hospital (No. 1786). Residual serum samples harvested for therapeutic drug monitoring were separated. Measured concentrations by LM1010 by the standard filter method (needs serum volume of > 400 μL) or the dilute method (needs serum volume of 150 μL) were compared with those by outsourcing, respectively. Acceptable measurement error range of 0.72–1.33 was considered. There were 69 serum samples, where the 35 or 34 samples were employed for evaluation of the standard filter method or the dilute method, respectively. Results The measured concentration using the standard filter method/outsourcing was 2.22/2.10 μg/mL as the median, 1.57–3.40/1.53–3.62 as the interquartile range, < 0.2–10.76/< 0.2–11.46 μg/mL as the range, while those using the dilute method/outsourcing was 2.36/2.29 μg/mL as the median, 1.08–2.94/1.03–3.06 as the interquartile range, 0.24–10.00/< 0.2–10.85 μg/mL as the range. The regression line for the standard filter method or the dilute method were y = 0.935x + 0.154 or y = 0.933x + 0.162, respectively. The standard filter method or the dilute method showed 11.4% samples (4/35, 95%CI 3.2–26.7%) or 8.8% samples (3/34, 95%CI 1.9–23.7%) out of the acceptable measurement error range, respectively. Conclusion Measurement of serum voriconazole concentration by LM1010 can be acceptable in clinical TDM practice.

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Therapeutic drug monitoring of voriconazole: validation of a novel ARK™ immunoassay and comparison with ultra-high performance liquid chromatography

Cited by 6 publications

References 27 publications

Performance evaluation of enzyme immunoassay for voriconazole therapeutic drug monitoring with automated clinical chemistry analyzers

Performance evaluation of enzyme immunoassay for voriconazole therapeutic drug monitoring with automated clinical chemistry analyzers

Therapeutic drug monitoring of voriconazole: validation of a high performance liquid chromatography method and comparison with an ARK immunoassay

Clinical evaluation of an authorized medical equipment based on high performance liquid chromatography for measurement of serum voriconazole concentration

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