Correlation between enzyme multiplied immunoassay technique and high-performance liquid chromatography in the quantification of voriconazole in a paediatric population.

ABSTRACT

The enzyme multiplied immunoassay technique (EMIT) is a new method for determining the plasma concentration of voriconazole (VRZ). This study aimed to investigate the correlation between EMIT and high-performance liquid chromatography/ultraviolet rays (HPLC/UV) in determining the plasma VRZ trough concentration in children, in China. A total of 419 blood samples were collected, and plasma VRZ concentrations were detected by the EMIT and HPLC methods. The results of 304 samples were analysed after excluding samples that were undetectable or beyond the quantification limit. A test result value of 0 was defined as undetectable, while concentrations outside the detection range (0.2 - 20.0 µg/ml for HPLC and 0.5 - 16.0 µg/ml for EMIT) were defined as beyond the quantification limit. Results from both methods were compared using the Passing Bablok regression, Bland-Altman plot analysis, and paired Wilcoxon test. The plasma VRZ concentrations determined by EMIT and HPLC showed a strong linear correlation through the linear regression equation YEMIT = 1.310 × HPLC +0.149 (R2 = 0.9082). The Bland-Altman plot analysis showed poor level consistency as measured by the two methods. The paired Wilcoxon-test showed a significant difference between the two methods (p < .0001). Compared to EMIT, HPLC accurately detected plasma VRZ concentration, making it suitable for VRZ therapeutic drug monitoring. The numerical values of the EMIT-measured levels were higher than those of HPLC, which may be related to VRZ metabolites interference and co-administrated drugs.