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Impact of chemiluminescent enzyme immunoassay screening for human parvovirus B 19 antigen in J apanese blood donors
Author(s) -
Sakata Hidekatsu,
Matsubayashi Keiji,
Ihara Hiromi,
Sato Shinichiro,
Kato Toshiaki,
Wakisaka Akemi,
Tadokoro Kenji,
Yu Meiying W.,
Baylis Sally A.,
Ikeda Hisami,
Takamoto Shigeru
Publication year - 2013
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2012.03949.x
Subject(s) - immunoassay , parvovirus , viral load , chemiluminescence , genotype , medicine , antigen , immunology , virology , chemistry , antibody , virus , chromatography , biochemistry , gene
Background To reduce the risk of human parvovirus B 19 ( B 19 V ) transmission through contaminated blood for transfusion and plasma‐derived products, the J apanese R ed C ross ( JRC ) B lood C enters 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 H okkaido, J apan, 101 were positive for B19V DNA . The 198 strains of B19V DNA –positive donations in H okkaido 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 J apan 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 B lood C enters can be an alternative approach to comply with recommendations regarding B19V in the United States and E urope.