Objectives: This study compared the performance of a fluorescent polarization immunoassay (FPIA) against HPLC-tandem mass spectrometry (HPLC-MS) for the measurement of everolimus in renal transplant recipients.
Design And Methods: A total of 333 pre-dose samples from 45 renal transplant patients were analyzed by FPIA and HPLC-MS.
Results: The inter-batch inaccuracy and precision of the FPIA for control samples were
Conclusions: The FPIA had acceptable analytical performance during the study but compared to HPLC-MS overestimated everolimus in patient samples. This overestimation is probably due to calibration differences between the methods and cross-reactivity of the FPIA antibody with everolimus metabolites. The clinical importance of the observed overestimation by FPIA requires further investigation.
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