Abstract
BackgroundHuman parvovirus B19 (B19V) is a frequent contaminant of blood and plasma-derived medicinal products. To ensure the quality and safety of plasma-derived products, European regulations, Plasma Protein Therapeutics Association (PPTA) standard and FDA guidelines require testing of manufacturing plasma for parvovirus B19 DNA to limit the load of this virus. In China, however, there have been no related documentation and technical guiding principles for monitoring B19V, moreover, an adequate level of information on the prevalence of B19V in Chinese plasma donations is not available.FindingsBy using an in-house quantitative polymerase chain reaction (qPCR) assay adapted for all three genotypes of B19V, 235 source plasma pools from three regional different Chinese manufacturers of blood products were screened and quantified. Results showed that 71.91 % (169/235) of plasma pools were contaminated by B19V, with the concentrations of 5.18 × 102–1.05 × 109 IU/mL. Approximately 31.95 % of the DNA-positive plasma pools were only moderately contaminated (<104 IU/mL), while 68.05 % contained >104 IU/mL.ConclusionsThe high level of B19V in plasma pools could present a great risk in plasma derivatives. Therefore, the implementation of B19V NAT (Nucleic Acid Testing) assays capable of detecting all B19V genotypes and discard donations with high titer B19V DNA for Chinese blood products manufacturers seems to be necessary.
Highlights
Human parvovirus B19 (B19V) is a frequent contaminant of blood and plasma-derived medicinal products
The high level of B19V in plasma pools could present a great risk in plasma derivatives
Human parvovirus B19 (B19V), a widespread human pathogen that be associated with a broad range of clinical manifestations, including erythema infectiosum, arthritis, transient aplastic crisis (TAC), chronic anemia, hydrops fetalis, and fetal death, can be transmitted via the administration of contaminated blood and plasma-derived products [1,2,3,4,5]
Summary
Human parvovirus B19 (B19V) is a frequent contaminant of blood and plasma-derived medicinal products. The implementation of B19V NAT (Nucleic Acid Testing) assays capable of detecting all B19V genotypes and discard donations with high titer B19V DNA for Chinese blood products manufacturers seems to be necessary. Administration (FDA), European Pharmacopoeia (Ph. Eur.) and the Plasma Protein Therapeutics Association (PPTA) have developed a list of standards, proposing a limit of 104 IU/ml for levels of B19V DNA in source plasma pools destined for manufacturing some or all kinds of plasma-derived products [6,7,8,9,10].
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