電気化学免疫測定法（ECLIA法）を用いたeverolimus血中濃度測定に関する臨床的評価

<p><b>【Objective】</b>Therapeutic drug monitoring (TDM) of everolimus is essential to maintain safety and efficacy in personalized immunosuppressive therapy. Several methodologies to measure the blood levels of everolimus are available. In this study, we aimed to evaluate a new automated electrochemiluminescence immunoassay (ECLIA) for measuring blood concentrations of everolimus in clinical practice.<br/><b>【Methods】</b>Spiked whole-blood samples were used to evaluate the performance of ECLIA. Residual EDTA whole-blood concentrations of everolimus in transplant patients were measured by ECLIA, liquid chromatography with tandem mass spectrometry (LC-MS/MS, n = 126), and latex agglutination (LA, n = 116). We also examined whether the simultaneous measurement of everolimus and tacrolimus was feasible.<br/><b>【Results】</b>The lower limitation of quantification of 0.22 ng/mL at 20% coefficient of variation was determined. Imprecision testing gave coefficients of variation less than 6% for both within-run and intermediate imprecisions. Values obtained by ECLIA were highly correlated with those of LC-MS/MS (ECLIA=1.128×LC-MS/MS+0.993; r=0.946), and LA (ECLIA= 0.981×LA + 1.245; r=0.964). A high correlation between the results of simultaneous measurement and independent measurement was observed for blood concentrations of everolimus and tacrolimus, respectively (r > 0.99).<br/><b>【Conclusion】</b>The ECLIA is a sensitive and useful method for routine TDM of everolimus.</p>