Assessment of electro chemiluminescence immunoassay method for measuring tacrolimus and cyclosporine A blood concentrations in clinical practice

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

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【Objective】Therapeutic drug monitoring (TDM) of tacrolimus and cyclosporine A is essential to maintain the safety and efficacy in personalized immunosuppressive therapy. This study was to evaluate the recently developed electro chemiluminescence immunoassay (ECLIA) method for measuring tacrolimus and cyclosporine A blood concentrations in clinical practice.<br/>【Methods】Spiked whole-blood samples were used to evaluate the performance of ECLIA. Whole-blood tacrolimus (n=160) or cyclosporine A (n=140) concentrations of transplanted patients were measured by ECLIA, chemiluminescence immunoassay (CLIA), affinity column mediated immune assay (ACMIA), and liquid chromatography with tandem mass spectrometry (LC-MS/MS).<br/>【Results】The ECLIA measurements of tacrolimus and cyclosporine A showed good performance in terms of sensitivity, repeatability, and specificity. Values obtained with the ECLIA were highly correlated with the CLIA for tacrolimus （ECLIA= 1.013×CLIA - 0.055; r=0.996）, with the LC-MS/MS for tacrolimus （ECLIA=0.945×LC-MS/MS ＋ 0.630; r=0.983）, with the ACMIA for cyclosporine A （ECLIA = 1.099×ACMIA - 18.999; r= 0.989） and with the LC-MS/MS for cyclosporine A （ECLIA = 0.890×LC-MS/MS ＋ 27.099; r= 0.977）.<br/>【Conclusion】The ECLIA is a sensitive and useful method to routinely monitor tacrolimus and cyclosporine A concentration in whole blood.

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