Impact of chemiluminescent enzyme immunoassay screening for human parvovirus B19 antigen in Japanese blood donors

Authors

  • Hidekatsu Sakata,

    Corresponding author
    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
    • Address reprint requests to: Hidekatsu Sakata, Japanese Red Cross Hokkaido Block Blood Center, 2-2 Yamanote, Nishi-ku, Sapporo 063-0002, Japan; e-mail: sakata@hokkaido.bc.jrc.or.jp.

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  • Keiji Matsubayashi,

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • Hiromi Ihara,

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • Shinichiro Sato,

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • Toshiaki Kato,

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • Akemi Wakisaka,

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • Kenji Tadokoro,

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • Mei-ying W. Yu,

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • Sally A. Baylis,

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • Hisami Ikeda,

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • Shigeru Takamoto

    1. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan
    2. Japanese Red Cross Plasma Fractionation Center, Chitose, Japan
    3. Japanese Red Cross Blood Service Headquarters, Tokyo, Japan
    4. Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
    5. Paul-Ehrlich-Institut, Langen, Germany
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  • There was no support for this article in the form of grants, equipment, or drugs.
  • The findings and conclusions in this article have not been formally disseminated by the FDA and should not be construed to represent any Agency determination or policy.

Abstract

Background

To reduce the risk of human parvovirus B19 (B19V) transmission through contaminated blood for transfusion and plasma-derived products, the Japanese Red Cross (JRC) Blood Centers introduced B19V antigen screening by chemiluminescent enzyme immunoassay (CLEIA-B19V) in 2008.

Study Design and Methods

Donor samples that were positive by CLEIA-B19V screening were tested for B19V DNA. The sensitivity of CLEIA-B19V was tested using samples of all three genotypes and B19V DNA–positive donations. B19V DNA–positive donations and pooled plasma were quantitatively assayed for B19V DNA. B19V DNA–positive donations were phylogenetically analyzed by polymerase chain reaction direct sequencing.

Results

The sensitivity of CLEIA-B19V was inferred to be approximately 6.3 log IU/mL with the genotype samples and 6.4 log IU/mL with B19V DNA–positive donor samples. Of 417 CLEIA-B19V–positive samples from 1,035,560 donations in Hokkaido, Japan, 101 were positive for B19V DNA. The 198 strains of B19V DNA–positive donations in Hokkaido over the past 15 years clustered exclusively with Genotype 1. After introduction of CLEIA-B19V, the viral load for B19V DNA in all 772 pooled plasma for fractionation from donors in nationwide Japan did not exceed 4 log IU/mL.

Conclusion

CLEIA-B19V can detect all three genotypes of B19V (viral load >6.3 log IU/mL) and limit the viral load (<4 log IU/mL) in pooled plasma, and thus such screening has further reduced the risk of transfusion-transmitted B19V infection. These results show that CLEIA-B19V screening at the JRC Blood Centers can be an alternative approach to comply with recommendations regarding B19V in the United States and Europe.

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