Research Article| Volume 18, SUPPLEMENT 2, 83-92, 1996

Hepatitis C virus screening and intravenous immunoglobulin safety in Japan

      This paper is only available as a PDF. To read, Please Download here.


      To obtain safe blood products, contaminants in source plasma must be eliminated through screening. Second-generation agglutination tests performed as part of donor screening have been shown to reduce the risk of hepatitis C virus (HCV) infection to 0.024% (1/4124) per unit of donated blood. These tests, as well as the third-generation enzyme-linked immunosorbent assay, significantly shortened the window of infectivity (the period between infection and antibody production) through more sensitive and specific recognition of anti-HCV antibodies in early-stage HCV infection. Earlier detection may reduce the risk of contamination of plasma with the high viral load that can be present in earlystage HCV infection without detectable anti-HCV antibodies. Because alanine aminotransferase levels increase before detectable seroconversion occurs in the window of infectivity, screening for alanine aminotransferase levels was found to be useful in determining which sources of plasma should be eliminated because of HCV contamination.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Clinical Therapeutics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Yei S
        • Yu MW
        • Tankersley DL
        Partitioning of hepatitis C virus during Cohn-Oncley fractionation of plasma.
        Transfusion. 1992; 32: 824-828
        • Centers for Disease Control
        Outbreak of hepatitis C associated with intravenous immunoglobulin administration: United States, October 1993–June 1994.
        MMWR. 1994; 43: 505-509
        • Bjoro K
        • Frøland SS
        • Zhibing Y
        • et al.
        Hepatitis C infection in patients with primary hypogammaglobulinemia after treatment with contaminated immunoglobulin.
        NEJM. 1994; 331: 1607-1611
        • Japanese Red Cross Non-A, Non-B Hepatitis Research Group
        Effect of screening for hepatitis C virus antibody and hepatitis B virus core antibody on incidence of post-transfusion hepatitis.
        Lancet. 1991; 338: 1040-1041
        • Watanabe J
        • Matsumoto C
        • Shimada T
        • et al.
        The predictive value of screening tests for persistent HCV infection evidenced by viremia: The Japanese experience.
        Vox Sang. 1993; 65: 199-203
        • Okamoto H
        • Okada S
        • Sugiyama Y
        • et al.
        Detection of hepatitis C virus RNA by a two-stage polymerase chain reaction with two pairs of primers deduced from the 5′ non-coding region.
        Jpn J Exp Med. 1990; 60: 215-222
        • Osaka K
        • Takahashi S
        • Shimizu M
        • Watanabe J
        The incidence of post-transfusion hepatitis after screening of donor blood for anti-HCV antibody by second generation of passive hemagglutination.
        Vox Sang. 1994; 67 (Abstract): 150
        • Sato S
        • Kishimoto S
        • Ihara H
        • et al.
        Evaluation of anti-hepatitis C virus screening using second-generation passive hemaglutination assay in donor blood.
        Vox Sang. 1994; 67 (Abstract): 98
        • Katayama T
        Post transfusion infection.
        (In: Ministry of Health and Welfare)in: Report of Viral Hepatitis Research Group. Ministry of Health and Welfare, Tokyo, Japan1994: 29-31
        • Mishiro S
        • Hoshi Y
        • Takeda Y
        • et al.
        Non-A non-B hepatitis specific antibodies directed at host-derived epitope: Implication for autoimmune process.
        Lancet. 1990; 336: 1400-1403
        • Arima T
        • Nagashima H
        Cloning of a cDNA associated with acute and chronic hepatitis C infection generated from patients' serum RNA.
        Gastroenterol Jpn. 1989; 24: 540-544
        • Dodd RY
        The risk of transfusion-transmitted infection.
        NEJM. 1992; 327: 941-950
        • Barrera JM
        • Francis B
        • Ercilla G
        • et al.
        Improved detection of anti-HCV in post-transfusion hepatitis by a third generation ELISA.
        Vox Sang. 1995; 68: 15-18
        • Kapprell HP
        • Majnak A
        • Medgyesi GA
        • et al.
        HCV core IgM and IgG antibodies in blood donors.
        Vox Sang. 1995; 68: 57-58
        • Dow BC
        • Follett EAC
        • Munro H
        • et al.
        Failure of 2nd- and 3rd-generation HCV ELISA and RIBA to detect HCV polymerase chain reaction-positive donations.
        Vox Sang. 1994; 67: 236-237
        • Virelink H
        • van der Poel CL
        • Reesink HW
        • et al.
        Transmission of hepatitis C virus by anti-HCV-negative blood transfusion.
        Vox Sang. 1995; 68 (Case report): 55-56
        • Blajchman MA
        • Bull SB
        • Feinman SV
        Post-transfusion hepatitis: Impact of non-A, non-B hepatitis surrogate tests.
        Lancet. 1995; 345: 21-25
        • Simons JN
        • Pilot-Matias T
        • Leary TP
        • et al.
        Identification of two flavivirus-like gnomes in the GB hepatitis agent.
        Proceedings of National Academy of Science USA. 1995; 92: 3401-3405
        • Kim JP
        • HXV Collaborative Working Group
        A new hepatitis virus.
        Presented at the US-Japan Hepatitis Panel Meeting. 241995; (Tokyo, Japan)