Assessment of four methodologies (microparticle enzyme immunoassay, chemiluminescent enzyme immunoassay, affinity column-mediated immunoassay, and flow injection assay-tandem mass spectrometry) for measuring tacrolimus blood concentration in Japanese liver transplant recipients.
Therapeutic drug monitoring (TDM) and subsequent dosage adjustment for individual patients in the treatment with tacrolimus are required after liver transplantation to prevent rejection and over-immunosuppression, which leads to severe infection and adverse reactions including nephrotoxicity. The purpose of this study was to evaluate the analytical performance among commercially available immunoassay methods, which were microparticle enzyme immunoassay (MEIA), chemiluminescent enzyme immunoassay (CLIA), and affinity column-mediated immunoassay (ACMIA), compared with an assay using liquid chromatography-tandem mass spectrometry (LC-MS/MS). In addition, the flow injection assay (FIA-MS/MS) was also evaluated to determine whether it could be available as a new method of analysis in tacrolimus therapy. The blood tacrolimus concentrations in samples from liver transplant recipients (n = 102) were measured using MEIA, CLIA, ACMIA, and LC-MS/MS. Additional blood samples from liver transplant recipients (n = 54) were analyzed using both FIA-MS/MS and LC-MS/MS. Because the assay performance and characteristics of MEIA, CLIA, ACMIA, and FIA-MS/MS are relatively different, the measured data should be carefully considered depending on the methodology.
Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
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Hashi
Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
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Masuda
Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
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Kikuchi
Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
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Uesugi
Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan; Department of Clinical Pharmacy and Education, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan.
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Yano
Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
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Omura
Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
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Yonezawa
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
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Fujimoto
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
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Ogawa
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
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Kaido
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
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Uemoto
Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan. Electronic address: kmatsuba@kuhp.kyoto-u.ac.jp.
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Matsubara
D006801:Humans; D007118:Immunoassay / Q000379:methods; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000097:blood*; D007564:Japan; D016031:Liver Transplantation; D049449:Luminescence; D016559:Tacrolimus / Q000008:administration & dosage / Q000097:blood*; D053719:Tandem Mass Spectrometry
D007166:Immunosuppressive Agents; D016559:Tacrolimus