The data indicate that the device successfully reduced the number of selected pathogens in PCs. Despite the fact that significant differences exist between treated and control in-vitro variables, it is speculated that the clinical effectiveness of both products will not be significantly different, based on comparison to historical data for products in routine clinical use today.
Riboflavin and UV light effectively reduced the titer of MERS-CoV in human plasma products to below the limit of detection, suggesting that the treatment process may reduce the risk of transfusion transmission of MERS-CoV.
The results from this work suggest that the riboflavin and UV light process may provide up to 98% protection against transfusion of bacterially contaminated units at the most clinically relevant contamination levels (<20 CFUs per product). This compares favorably to the 60% to 66% effectiveness of bacterial culture testing using a 48-hour quarantine period before product release.
The study was undertaken as a proof of principle with the aim to demonstrate (i) the quality, stability and suitability of the bacterial strains for low-titre spiking of blood components, (ii) the property of donor-independent proliferation in PCs, and (iii) their suitability for worldwide shipping of deep frozen, blinded pathogenic bacteria. These aims were successfully fulfilled. The WHO Expert Committee Biological Standardisation has approved the adoption of these four bacteria strains as the first Repository for Transfusion-Relevant Bacteria Reference Strains and, additionally, endorsed as a project the addition of six further bacteria strain preparations suitable for control of platelet contamination as the next step of enlargement of the repository.
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