Development of a method of serum dabigatran concentration assay using anti-dabigatran monoclonal antibody

2014 Fiscal Year Final Research Report

• Project/Area Number: 24659355
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: General internal medicine (including Psychosomatic medicine)
• Research Institution: Nagasaki International University
• Principal Investigator: OISO Shigeru 長崎国際大学, 薬学部, 准教授 (40513106)
• Co-Investigator(Kenkyū-buntansha): KARIYAZONO Hiroko 長崎国際大学大学院, 薬学研究科, 教授 (20437958) ; MORINAGA Osamu 長崎国際大学大学院, 薬学研究科, 准教授 (60465771)
• Project Period (FY): 2012-04-01 – 2015-03-31
• Keywords: ダビガトラン / モノクローナル抗体 / ELISA / 血中濃度 / リンゲル液

Outline of Final Research Achievements

Dabigatran (DT) is a direct thrombin inhibitor used for the prevention of venous and arterial thromboembolism. DT produces an increased incidence of bleeding in patients with renal dysfunction. Circulating levels of DT are increased in such patients because it is mainly eliminated by renal excretion. To measure DT concentration, we developed a novel enzyme-linked immunosorbent assay (ELISA) using an anti-DT monoclonal antibody (DT-mAb) which was generated by immunization of mice with a DT-keyhole limpet hemocyanin conjugate. The measurement range of dabigatran in competitive ELISA using DT-mAb was 7.8-125 ng/mL. The ELISA signal was not linear using DT-spiked serum in the concentration range of 7.8-125 ng/mL, but was linear when serum ultrafiltrate was used. These results suggested that this competitive ELISA may provide an analysis tool for the determination of free DT in serum ultrafiltrate during therapeutic drug monitoring and pharmacokinetic studies.

Free Research Field

医療薬学