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Screening for parvovirus B19 antigen through chemiluminescent enzyme immunoassay is equivalent to B19 nucleic acid amplification test‐based screening of pooled plasma
Author(s) -
Ikegawa Motonori,
Ohashi Shinichi,
Minagi Takao,
Okamoto Hiroko,
Yunoki Mikihiro
Publication year - 2021
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/trf.16512
Subject(s) - immunoassay , chemiluminescence , nat , parvovirus , medicine , antigen , nucleic acid test , virology , immunology , virus , chemistry , antibody , disease , chromatography , covid-19 , infectious disease (medical specialty) , computer science , computer network
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 10 4 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.