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

Jeon, Yongbum; Han, Minje; Han, Eun Young; Lee, Kyung Hoon; Song, Junghan; Song, Sang Hoon

doi:10.1016/j.plabm.2017.05.002

Cited by 11 publications

(6 citation statements)

References 29 publications

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“…Similar to our study, the Bland-Altman plot also revealed a slight overestimation of the EIA over the UPLC with a systematic error of −0.29 mg/L. The second study is a validation of an ARK immunoassay method and comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) 24. In this second study a good correlation was also observed, with a correlation coefficient of 0.98 between both methods.…”

Section: Discussionsupporting

confidence: 86%

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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Section: Discussionsupporting

confidence: 86%

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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“…5 An overestimation was observed with the ARK TM immunoassay, which has also been described when this immunoassay is applied on other analysers. 3,4,6 According to our study, in most samples, both techniques led to similar dose recommendations. Nonetheless, they could differ with concentrations near the lower limit of the therapeutic range, leading to no change in patients who would need an increase of dose when the enzyme immunoassay is used.…”

Section: Discussionsupporting

confidence: 69%

“…However, the immunoassay showed up >20% between-day variation for the concentrations ≤1 μg/ml. This value is higher than that obtained by Cattoir et al 3 (<6.8%) and Yongbum et al 4 (<3%) and could be related to the application of the assay to an Architect c4000 analyser instead of to a Modular P800 (Roche) or TBA-200FR (Toshiba).…”

Section: Discussioncontrasting

confidence: 64%

Comparison of ultra-performance liquid chromatography and ARK immunoassay for therapeutic drug monitoring of voriconazole

et al. 2021

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Background 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. Methods Linearity, precision and accuracy of both methods were validated according to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) 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.

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“…While it may be ideal to have assays performed on site, the cost of developing and running assays may mean that many TDM services are available only in specialist centres. Hitherto, measurements of antifungal concentrations in body fluids are easily accessible to clinical laboratories by bioassay (except for itraconazole) or the new simple, low-cost enzyme immunoassays using automated clinical chemistry analysers [54].…”

Section: Discussionmentioning

confidence: 99%

Antifungal therapeutic drug monitoring: focus on drugs without a clear recommendation

Gómez-López

2020

Clinical Microbiology and Infection

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Background: The goal of therapeutic drug monitoring (TDM) is to determine the appropriate exposure of difficult-to-manage medications to optimize the clinical outcomes in patients in various clinical situations. Concerning antifungal treatment, and knowing that this procedure is expensive and timeconsuming, TDM is particularly recommended for certain systemic antifungals: i.e., agents with a well-defined exposureeresponse relationship and unpredictable pharmacokinetic profile or narrow therapeutic index. Little evidence supports the routine use of TDM for polyenes (amphotericin B), echinocandins, fluconazole or new azoles such as isavuconazole, despite the fact that a better understanding of antifungal exposure may lead to a better response. Aims: The aim of this work is to review published pharmacokinetic/pharmacodynamic data on systemically administered antifungals, focusing on those for which monitoring is not routinely recommended by experts. Sources: A MEDLINE search of the literature in English was performed introducing the following search terms: amphotericin B, fluconazole, itraconazole, voriconazole, posaconazole, triazoles, caspofungin, micafungin, anidulafungin, echinocandins, pharmacokinetics, pharmacodynamics, and therapeutic drug monitoring. Review articles and guidelines were also screened. Content: This review collects different pharmacokinetic/pharmacodynamic aspects of systemic antifungals and summarizes recent threshold values for clinical outcomes and adverse events. Although for polyenes, echinocandins, fluconazole and isavuconazole extensive clinical validation is still required for a clear threshold and a routine monitoring recommendation, particular points such as liposome structure or complex pathophysiological conditions affecting final exposure are discussed. For the rest, their better-defined exposureeresponse/toxicity relationships allow access to useful threshold values and to justify routine monitoring. Additionally, clinical data are needed to better define thresholds that can minimize the development of antifungal resistance. Implications: General TDM for all systemic antifungals is not recommended; however, this approach may help to establish an adequate antifungal exposure for a favourable response, prevention of toxicity or development of resistance in special clinical circumstances.

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

Cited by 11 publications

References 29 publications

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

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

Comparison of ultra-performance liquid chromatography and ARK immunoassay for therapeutic drug monitoring of voriconazole

Antifungal therapeutic drug monitoring: focus on drugs without a clear recommendation

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