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

Background To reduce the risk of human parvovirus B19 ( B19 V) 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. [ABSTRACT FROM AUTHOR]