ESTABLISHMENT OF THE FIRST NATIONAL STANDARD FOR NUCLEIC ACID AMPLIFICATION TECHNOLOGY ASSAY FOR HCV RNA

  • Mizusawa Saeko
    Department of Blood and Safety Research, The National Institute of Infectious Diseases Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Okada Yoshiaki
    Department of Blood and Safety Research, The National Institute of Infectious Diseases Subcommittee on Safety for Plasma-Derived Products Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Horiuchi Yoshinobu
    Department of Bacteriology II, The National Institute of Infectious Diseases Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Tanaka Takeshi
    Japanese Red Cross Saitama Blood Center Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Sato Koei
    Japanese Red Cross Saitama Blood Center Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Kaneko Kenji
    Nihon Pharmaceutical Co. Ltd. Subcommittee on Safety for Plasma-Derived Products Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Sasaki Yuko
    Benesis Corporation Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Tanaka Toshiaki
    Baxter Limited BioScience Subcommittee on Safety for Plasma-Derived Products
  • Tomono Tsugikazu
    Japanese Red Cross Plasma Fractionation Center Subcommittee on Safety for Plasma-Derived Products
  • Tomomizu Takeo
    Nihon Pharmaceutical Co. Ltd. Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Hayami Shouichi
    Benesis Corporation Subcommittee on Safety for Plasma-Derived Products Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Hijikata Minako
    Department of Medical Science, Toshiba General Hospital Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay Present address; Department of Respiratory Diseases, Research Institute, International Medical Center of Japan
  • Hirako Ichiro
    Bayer Yakuhin Ltd. Subcommittee on Safety for Plasma-Derived Products Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay Present address; Schering-Plough K. K.
  • Mayumi Makoto
    Jichi Medical School Subcommittee on Safety for Plasma-Derived Products
  • Mikami Koichi
    Aventis Pharma Co. Ltd. Subcommittee on Safety for Plasma-Derived Products Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay Present address; Bayer Yakuhin, Ltd.
  • Mishiro Shunji
    Department of Medical Science, Toshiba General Hospital Subcommittee on Safety for Plasma-Derived Products Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Miyamoto Seiji
    The Chemo-Sero-Therapeutic Research Institute Subcommittee on Safety for Plasma-Derived Products Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Muta Kengo
    The Chemo-Sero-Therapeutic Research Institute Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Komuro Katsutoshi
    Department of Blood and Safety Research, The National Institute of Infectious Diseases Subcommittee on Safety for Plasma-Derived Products
  • Yamaguchi Teruhide
    Division of Cellular and Gene Therapy Products, National Institute of Health Science Subcommittee on Safety for Plasma-Derived Products National Institute of Health Sciences
  • Weimer Thomas
    Aventis Behring Ltd. Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
  • Gierman Todd
    Bayer Healthcare Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay

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Other Title
  • C型肝炎ウイルスRNAの遺伝子検査法のための第一次国内標準品の作製

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Description

The First WHO International Standard for HCV RNA for Nucleic Acid Amplification Technology (NAT) Assay (96/790) was established in 1997. The aim of our collaborative study was the establishment of the Japanese National Standard for HCV RNA calibrated against the WHO International Standard. The candidate materials were evaluated in the following two steps. First, titers of two HCV positive plasma (119 and 122) diluted in cryosupernatant were evaluated, and plasma 122 was chosen as the source plasma for the candidate for the national standard. Then, candidate 122 was prepared by diluting the source plasma to approximately 105 international units (IU)/ml in cryosupernatant. The relative potency of the candidate was measured against the International Standard by the end-point method. Seven laboratories from three countries participated in the collaborative study. Four laboratories used the Roche Amplicor assay (Version 1) and 3 laboratories used in-house PCR methods. There was reasonable agreement among the mean estimates from the laboratories. The overall mean potency of the candidate relative to the International Standard was 105.00 (104.80-105.20) IU/ml. The sample was accepted as the first Japanese national standard and assigned a titer of 100, 000IU/ml. Each vial of the National Standard contains 0.5ml of HCV plasma (genotype 1b) diluted in cryosupernatant and should be stored at-80°C.

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