Analysis of B19 virus contamination in plasma pools for manufacturing, by using a competitive polymerase chain reaction assay

Background and Objectives The presence of B19 virus in blood poses a risk of transmission of the virus via blood or blood products. Screening processes for manufacturing should be aimed at achieving production plasma pools with B 19 virus contamination levels below 10(4) genome equivalents/ml (geq/ml) in order to prevent transmission of infection through plasma derivatives. Materials and Methods The suitability of a competitor plasmid as an internal analytical standard for the detection of B 19 virus in plasma pools was assessed by using a competitive polymerase chain reaction (PCR) assay. Seventy-five plasma pools, each consisting of 960 single donations, were analysed for B19 virus contamination following a lysis treatment. Results The amount of competitor plasmid in the competitive PCR assay established, with good accuracy, a threshold value for discrimination of the viral load in plasma pools. Analysis of samples from plasma pools showed that 12% of pools were contaminated with B 19 virus at levels above the set threshold value. Conclusions The competitive PCR assay developed proved to be effective for discrimination of the B 19 virus contamination level in screening of plasma pools for manufacturing.