Performance Evaluation of INNOVANCE<sup>®</sup> VWF Ac Assay employing recombinant glycoprotein Ib mutant

DOI Web Site 19 References
  • Suzuki Atsuo
    Department of Medical Technique, Nagoya University Hospital
  • Suzuki Nobuaki
    Department of Transfusion Medicine, Nagoya University Hospital
  • Kanematsu Takeshi
    Department of Clinical Laboratory, Nagoya University Hospital
  • Okamoto Shuichi
    Department of Hematology-Oncology, Nagoya University Graduate School of Medicine
  • Tamura Shogo
    Department of Pathophysiological Laboratory Sciences, Nagoya University Graduate School of Medicine
  • Shinohara Sho
    Sysmex Corporation
  • Arai Nobuo
    Sysmex Corporation
  • Kikuchi Ryosuke
    Department of Medical Technique, Nagoya University Hospital
  • Ando Yoshitaka
    Department of Medical Technique, Nagoya University Hospital
  • Kojima Tetsuhito
    Department of Pathophysiological Laboratory Sciences, Nagoya University Graduate School of Medicine
  • Matsushita Tadashi
    Department of Transfusion Medicine, Nagoya University Hospital Department of Clinical Laboratory, Nagoya University Hospital

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  • 血小板膜糖蛋白質GPIb変異体を用いたvon Willebrand因子活性測定試薬「INNOVANCE<sup>®</sup> VWF Ac」の基本性能評価

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Abstract

<p>The measurement of von Willebrand factor (VWF) activity and antigen (Ag) are required to diagnose von Willebrand disease (VWD). In Japan, ristocetin cofactor activity of VWF (VWF:RCo) has been used in a clinical setting. INNOVANCE® VWF Ac Assay is based on latex immunoagglutination and measures VWF:GPIbM activity, which employ recombinant glycoprotein Ib carrying two gain-of-function mutation. However, it has not been introduced in Japan yet. Here, we evaluated the performance of INNOVANCE® VWF Ac Assay in CS-5100 autoanalyzer. The results showed that within-run and between-day precision were the CVs of <3% and <2%, respectively. We observed a good dilution linearity and a superior limit of detection compared with VWF:RCo. The VWF:GPIbM assay was not affected by interference substances such as bilirubin, hemolytic hemoglobin and chyle, and also by unfractionated heparin (<10 IU/mL). The correlations of VWF:GPIbM versus VWF:RCo or VWF:Ag were excellent in normal plasma. In plasma from patients with VWD, VWF:GPIbM activity was also correlated with VWF:RCo. Taken together, INNOVANCE® VWF Ac Assay showed a remarkable performance and it would be expected the future introduction in Japan.</p>

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