title: Impact of chemiluminescent enzyme immunoassay screening for human parvovirus B19 antigen in Japanese blood donors.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan; Japanese Red Cross Plasma Fractionation Center, Chitose, Japan; Japanese Red Cross Blood Service Headquarters, Tokyo, Japan; Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland; Paul-Ehrlich-Institut, Langen, Germany.
authors.forename: Hidekatsu
authors.initials: H
authors.lastname: Sakata
authors.forename: Keiji
authors.initials: K
authors.lastname: Matsubayashi
authors.forename: Hiromi
authors.initials: H
authors.lastname: Ihara
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Sato
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Kato
authors.forename: Akemi
authors.initials: A
authors.lastname: Wakisaka
authors.forename: Kenji
authors.initials: K
authors.lastname: Tadokoro
authors.forename: Mei-ying W
authors.initials: MY
authors.lastname: Yu
authors.forename: Sally A
authors.initials: SA
authors.lastname: Baylis
authors.forename: Hisami
authors.initials: H
authors.lastname: Ikeda
authors.forename: Shigeru
authors.initials: S
authors.lastname: Takamoto
mesh_terms: D000465:Algorithms; D000918:Antibody Specificity; D000956:Antigens, Viral / Q000097:blood*; D001782:Blood Donors / Q000706:statistics & numerical data; D004279:DNA, Viral / Q000097:blood / Q000235:genetics; D006801:Humans; D007124:Immunoenzyme Techniques; D007564:Japan / Q000453:epidemiology; D008163:Luminescent Measurements / Q000379:methods*; D008403:Mass Screening / Q000379:methods; D010322:Parvoviridae Infections / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology; D016732:Parvovirus B19, Human / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D010802:Phylogeny; D016133:Polymerase Chain Reaction / Q000379:methods; D012698:Serologic Tests / Q000379:methods; D019562:Viral Load
chemical_list: D000956:Antigens, Viral; D004279:DNA, Viral