Residual risk of transfusion-transmitted hepatitis B virus (HBV) infection caused by blood components derived from donors with occult HBV infection in Japan

Authors

  • Rikizo Taira,

    1. From the Blood Service Headquarters and Central Blood Institute, Japanese Red Cross; and the Japanese Red Cross Kanto-Koshin'etsu Block Blood Center, Tokyo, Japan.
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  • Masahiro Satake,

    Corresponding author
    1. From the Blood Service Headquarters and Central Blood Institute, Japanese Red Cross; and the Japanese Red Cross Kanto-Koshin'etsu Block Blood Center, Tokyo, Japan.
      Masahiro Satake, MD, Japanese Red Cross Central Blood Institute, Tatsumi 2-1-67, Koto-ku, Tokyo 135-8521, Japan; e-mail: m-satake@jrc.or.jp.
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  • Shun'ya Momose,

    1. From the Blood Service Headquarters and Central Blood Institute, Japanese Red Cross; and the Japanese Red Cross Kanto-Koshin'etsu Block Blood Center, Tokyo, Japan.
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  • Satoru Hino,

    1. From the Blood Service Headquarters and Central Blood Institute, Japanese Red Cross; and the Japanese Red Cross Kanto-Koshin'etsu Block Blood Center, Tokyo, Japan.
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  • Yoshiharu Suzuki,

    1. From the Blood Service Headquarters and Central Blood Institute, Japanese Red Cross; and the Japanese Red Cross Kanto-Koshin'etsu Block Blood Center, Tokyo, Japan.
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  • Hiroyuki Murokawa,

    1. From the Blood Service Headquarters and Central Blood Institute, Japanese Red Cross; and the Japanese Red Cross Kanto-Koshin'etsu Block Blood Center, Tokyo, Japan.
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  • Shigeharu Uchida,

    1. From the Blood Service Headquarters and Central Blood Institute, Japanese Red Cross; and the Japanese Red Cross Kanto-Koshin'etsu Block Blood Center, Tokyo, Japan.
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  • Kenji Tadokoro

    1. From the Blood Service Headquarters and Central Blood Institute, Japanese Red Cross; and the Japanese Red Cross Kanto-Koshin'etsu Block Blood Center, Tokyo, Japan.
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Masahiro Satake, MD, Japanese Red Cross Central Blood Institute, Tatsumi 2-1-67, Koto-ku, Tokyo 135-8521, Japan; e-mail: m-satake@jrc.or.jp.

Abstract

BACKGROUND: Nucleic acid amplification testing (NAT) for hepatitis B virus (HBV) during blood screening has helped to prevent transfusion-transmitted HBV infection (TT-HBV) in Japan. Nevertheless, 4 to 13 TT-HBV infections arise annually.

STUDY DESIGN AND METHODS: The Japanese Red Cross (JRC) analyzed repository samples of donated blood for TT-HBV that was suspected through hemovigilance. Blood donations implicated in TT-HBV infections were categorized as either window period (WP) or occult HBV infection (OBI) related. In addition, we analyzed blood from 4742 donors with low antibody to hepatitis B core antigen (anti-HBc) and antibody to hepatitis B surface antigen (anti-HBs) titers using individual-donation NAT (ID-NAT) to investigate the relationship between anti-HBc titer and proportion of viremic donors.

RESULTS: Introduction of a more sensitive NAT method for screening minipools of 20 donations increased the OBI detection rate from 3.9 to 15.2 per million, while also the confirmed OBI transmission rate increased from 0.67 to 1.49 per million. By contrast the WP transmission rate decreased from 0.92 to 0.46 per million. Testing repository samples of donations missed by minipools of 20 donations NAT showed that 75 and 85% of TT-HBV that arose from WP and OBI donations, respectively, would have been interdicted by ID-NAT. The ID-NAT trial revealed that 1.94% of donations with low anti-HBc and anti-HBs titers were viremic and that anti-HBc titers and the frequency of viremia did not correlate.

CONCLUSIONS: The JRC has elected to achieve maximal safety by discarding all units with low anti-HBc and anti-HBs titers that account for 1.3% of the total donations.

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