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ESTABLISHMENT OF THE FIRST NATIONAL STANDARD FOR NUCLEIC ACID AMPLIFICATION TECHNOLOGY ASSAY FOR HCV RNA
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- 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
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- 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
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- 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
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- Tanaka Takeshi
- Japanese Red Cross Saitama Blood Center Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
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- Sato Koei
- Japanese Red Cross Saitama Blood Center Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
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- 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
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- Sasaki Yuko
- Benesis Corporation Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
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- Tanaka Toshiaki
- Baxter Limited BioScience Subcommittee on Safety for Plasma-Derived Products
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- Tomono Tsugikazu
- Japanese Red Cross Plasma Fractionation Center Subcommittee on Safety for Plasma-Derived Products
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- Tomomizu Takeo
- Nihon Pharmaceutical Co. Ltd. Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
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- Hayami Shouichi
- Benesis Corporation Subcommittee on Safety for Plasma-Derived Products Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
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- 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
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- 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.
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- Mayumi Makoto
- Jichi Medical School Subcommittee on Safety for Plasma-Derived Products
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- 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.
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- 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
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- 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
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- Muta Kengo
- The Chemo-Sero-Therapeutic Research Institute Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
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- Komuro Katsutoshi
- Department of Blood and Safety Research, The National Institute of Infectious Diseases Subcommittee on Safety for Plasma-Derived Products
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- 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
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- Weimer Thomas
- Aventis Behring Ltd. Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
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- Gierman Todd
- Bayer Healthcare Working Group on the Establishment of National Standards for Nucleic Acid Technology Assay
Bibliographic Information
- Other Title
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- 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.
Journal
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- Journal of the Japan Society of Blood Transfusion
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Journal of the Japan Society of Blood Transfusion 51 (5), 515-519, 2005
The Japan Society of Transfusion Medicine and Cell Therapy
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Keywords
Details 詳細情報について
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- CRID
- 1390282679885230464
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- NII Article ID
- 130003853237
- 10016792957
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- NII Book ID
- AN00198368
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- ISSN
- 18838383
- 05461448
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- Text Lang
- ja
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- Data Source
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- JaLC
- Crossref
- CiNii Articles
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- Abstract License Flag
- Disallowed