RESUMEN
BACKGROUND: Human parvovirus B19 (B19) is a pathogen that threatens the quality of plasma products. Therefore, health authorities have mandated measures against B19 contamination of plasma pools. The US FDA has recommended a B19 genome level of 104 IU/ml or lower in pooled plasma lots. Therefore, the B19 nucleic acid amplification test (B19-NAT) has been introduced in many plasma fractionators. However, in the Japanese Red Cross, which is the only approved blood collector in Japan, the B19 antigen test has been introduced for screening donated blood in Japan. Therefore, to clarify whether the antigen test is robust enough to screen blood samples according to the FDA recommendation, we evaluated B19 genome levels in each pooled plasma lot from 2003 to 2020. STUDY DESIGN AND METHODS: Data of 5576 pooled plasma lots from factories A and B, which were derived from plasma bags and passed the B19 antigen-based tests, receptor-mediated hemagglutination assay (B19-RHA), or chemiluminescent enzyme immunoassay (B19-CLEIA), during 2003 to 2020, were evaluated. The amount of B19 genome in each lot was determined using quantitative or semiquantitative B19-NAT. RESULTS: The B19 genome levels in pooled plasma lots screened using B19-RHA did not meet the FDA recommendation, whereas the lots derived from B19-CLEIA fulfilled the FDA recommendation, even during the B19 epidemic in Japan. DISCUSSION: The results suggest that the B19-CLEIA donor screening for plasma pools is also useful in light of the US FDA recommendation.
