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 <or=6% and <or=13.0%, respectively (n = 17). The comparison of patient results yielded the Deming regression equation FPIA = 1.19 x HPLC-MS + 0.51. The mean bias was 24.4% (95% CI: -3.0 to 54.2%, range: -30.1% to 79.4%). 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.
RCT Entities:
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 <or=6% and <or=13.0%, respectively (n = 17). The comparison of patient results yielded the Deming regression equation FPIA = 1.19 x HPLC-MS + 0.51. The mean bias was 24.4% (95% CI: -3.0 to 54.2%, range: -30.1% to 79.4%). 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.
Authors: Björn Schniedewind; Stefanie Niederlechner; Jeffrey L Galinkin; Kamisha L Johnson-Davis; Uwe Christians; Eric J Meyer Journal: Ther Drug Monit Date: 2015-06 Impact factor: 3.681