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

Abstract

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.

Quantitative evaluation and chromatographic fingerprinting for the quality assessment of Pudilan tablet

“…This technique has been applied by the World Health Organization (WHO), the State Food and Drug Administration of China (SFDA) as a strategic plan for the quality assessment of TCM [9,10], and got increasing concerns because it focuses on the characterization of the total sample composition. Several ways, for instance, high-performance thin layer chromatography (HPTLC) [11][12][13][14], thin-layer chromatography (TLC) [15][16][17], infrared spectroscopy (IR) [18][19][20], mass spectrometry (MS) [21,22], gas chromatography (GC) [23,24], high-performance liquid chromatography (HPLC) [25][26][27], nuclear magnetic resonance (NMR) [28][29][30][31] and high-performance liquid chromatography (UPLC) [32][33][34] are utilized for fingerprinting to characterize multiple compounds in the tested herbal samples. Among the abovementioned methods, HPLC is generally the most applied method for its high sensitivity, selectivity, and low cost [35].…”

Comparison of LC-MS3 and LC-MRM Method for Quantifying Voriconazole and Its Application in Therapeutic Drug Monitoring of Human Plasma

“…For TDM of voriconazole, there are many analytical assays have been developed, such as immunoassays [ 6 ], high-performance liquid chromatography (HPLC) [ 7 ], gas chromatography mass spectrometry (GC-MS) [ 8 ] and liquid chromatography tandem mass spectrometry (LC-MS/MS) [ 9 ]. However, when a value close to the lower limit of the therapeutic range, an overestimation of immunoassay (systematic error of 0.39 μg/mL) is detected [ 10 ] and the enzyme multiplied immunoassay technique (EMIT)-measured levels are higher than those of HPLC [ 11 ]. Compared with HPLC assays with ultraviolet or fluorescence detection, the LC-MS/MS assays have improved selectivity, sensitivity, accuracy and precision.…”

Rapid Quantitative Detection of Voriconazole in Human Plasma Using Surface-Enhanced Raman Scattering

“…At present, the detection of VRC in human biofluids such as serum, plasma, and urine is commonly achieved via the use of high-performance liquid chromatography (HPLC), liquid chromatography–mass spectrometry (LC–MS), and immunoassay. , Although the chromatography methods are reliable and accurate, the operations are complex and time-consuming, which affect the detection efficiency of therapeutic drug monitoring. In addition, professionally trained personnel with related background knowledge and expertise are required.…”

“…In addition, professionally trained personnel with related background knowledge and expertise are required. Immunoassay cannot achieve the identification of the specific chemical structure of VRC . These disadvantages hinder the development of new analytical protocols for on-site detection and monitoring of drugs in various biological fluids.…”

“…Immunoassay cannot achieve the identification of the specific chemical structure of VRC. 8 These disadvantages hinder the development of new analytical protocols for on-site detection and monitoring of drugs in various biological fluids. To meet the urgent clinical needs, the development of a simple, rapid, assay for point-of-care detection of VRC is imperative.…”