A novel quantitative <i>JAK2</i>V617F detection kit: prospective clinical performance study comparing MPN patients and healthy subjects

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  • KIRITO Keita
    Department of Hematology and Oncology, Yamanashi University
  • KOIKE Michiaki
    Department of Hematology, Juntendo University Shizuoka Hospital
  • NOGUCHI Masaaki
    Department of Hematology, Juntendo University Urayasu Hospital
  • KIZAKI Masahiro
    Department of Hematology, Saitama Medical Center, Saitama Medical University
  • KATAYAMA Naoyuki
    Department of Hematology and Oncology, Mie University Graduate School of Medicine
  • SUGIMOTO Yuka
    Department of Hematology and Oncology, Mie University Graduate School of Medicine
  • DOBASHI Nobuaki
    Department of Clinical Oncology and Hematology, The Jikei University Daisan Hospital
  • USUI Noriko
    Department of Clinical Oncology and Hematology, The Jikei University Daisan Hospital
  • KOMATSU Norio
    Department of Hematology, Juntendo University School of Medicine

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Other Title
  • 骨髄増殖性腫瘍症例および健常者を対象にした新規<i>JAK2</i>V617F変異量測定キットの臨床性能試験
  • 臨床研究 骨髄増殖性腫瘍症例および健常者を対象にした新規JAK2V617F変異量測定キットの臨床性能試験
  • リンショウ ケンキュウ コツズイ ゾウショクセイ シュヨウ ショウレイ オヨビ ケンジョウシャ オ タイショウ ニ シタ シンキ JAK2V617F ヘンイリョウ ソクテイ キット ノ リンショウ セイノウ シケン

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Abstract

<p>The JAK2V617F mutation is the commonest major genetic mutation of myeloproliferative neoplasms (MPNs) and has been defined in the WHO diagnostic criteria for MPNs. However, there is still no approved in vitro diagnostic test kit available in Japan. We evaluated a JAK2V617F allele quantification kit (test method) in a prospective, multicenter clinical performance study involving patients with MPNs who were diagnosed with polycythemia vera, essential thrombocythemia, and primary myelofibrosis; healthy volunteers were also included in the analysis. Good correlation was observed between the allele burden determined using the test method vs. that determined using next-generation sequencing (NGS) in the patient group (r=0.998, y=1.071x−0.069; n=156). Furthermore, all allele burdens in the healthy group (n=54) were below the lower limit of the measurement range of the test method (0.042%). Our results confirmed that the test method could quantitatively measure the JAK2V617F allele burden in patients with MPN. Thus, the novel JAK2V617F allele quantification kit can be considered useful for the diagnosis of MPNs.</p>

Journal

  • Rinsho Ketsueki

    Rinsho Ketsueki 59 (6), 669-674, 2018

    The Japanese Society of Hematology

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