Development and validation of a simple and rapid XXXX assay for @entity1092 and its comparison to Immunoassay and @entity2101 methods.

@entity1 @entity3262 @entity3928 @entity1092 @entity1626 @entity2101 @entity5189
BACKGROUND: @entity1092 ( @entity3262 ), a widely used antiepileptic drug, has a narrow therapeutic range of 50-100  g/mL and shows large individual variability. It is very important to monitor the trough concentration of @entity3262 using a reliable method. Therefore the aim of this study was to develop and validate a rapid @entity3928 ( @entity3928 ) method for quantification of @entity3262 in human serum and to compare with fluorescence polarization immunoassay (FPIA), chemiluminescence microparticle immunoassay (CMIA) and @entity2101 ( @entity2101 ) methods METHODS:: The method included the extraction of @entity3262 in serum by deproteinization with @entity1626 . The analysis was carried out using a EC-C18 column (2.7  m, 4.6 mm*50 mm) under isocratic conditions with a mobile phase of @entity1626 /water (containing 0.1% @entity5189 ) (45/55, v/v) at a flow rate of 0.6 mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer using an electrospary probe in the negative ionization mode. The method was validated by studies of selectivity, linearity, lower limit of quantification, accuracy, precision, recovery, matrix effect and stability. Furthermore, all the four methods including FPIA, CMIA and @entity2101 were subsequently used to assay the @entity3262 concentration in 498 clinical serum samples collected from @entity1 received @entity3262 . These methods were compared by Deming regression and Bland-Altman analysis. RESULTS: The retention time of @entity3262 was 2.09 minutes. The calibration curve was linear over the concentration range of 1-200  g/mL, with a lower limit of quantification of 1  g/mL. The inter- and intra-day precision (RSD %) was less than 4.6 % and 4.5 %, respectively, and the accuracy (RE %) was below 7.9 %. The recoveries and matrix effect of @entity3262 at concentrations of 2, 50 and 160  g/mL met the requirement for the analysis of biological samples. No obvious degradation of @entity3262 was observed under various storage conditions including room temperature for 12h, three freeze-thaw cycles and -20  C for 3 month. Regression analysis showed that the correlation coefficients for the @entity3928 versus FPIA, CMIA, and @entity2101 were 0.989, 0.988 and 0.987 respectively. The results of agreement tests between @entity3928 and other methods showed that the mean difference of @entity3928 and FPIA was -1.4   g/mL and 95% confidence interval of -7.7 to 4.9   g/mL, and the values for @entity3928 and CMIA were -0.8   g/mL and -7.5 to 5.8   g/mL, for @entity3928 and @entity2101 were 1.1   g/mL and -5.7 to 7.9   g/mL. CONCLUSION: The rapid @entity3928 method we developed showed a good analytical performance required for TDM, leading to potential improvements in @entity1 care and laboratory management. Compared to the FPIA, CMIA and @entity2101 methods, the @entity3928 method correlated well and displayed comparable @entity3262 concentrations.
