Pathogen reduction in human plasma treated with Riboflavin and UV light: impact on coagulation factor VIII
AbstractBackground: Pathogen reduction system is expected to effectively reduce pathogen load of blood components while simultaneously maintaining the quality of cells and proteins. Pathogen reduction in human plasma treated with a combination of riboflavin (vitamin B2) and UV light is based on irreversible, oxydative damage of nucleic acids. In this way it prevents further replication of viruses, bacteria and parasites eventually present in the plasma. The aim of our study was to evaluate the influence of photo-inactivation process on the coagulation factor VIII (FVIII) present in plasma. Methods: We have tested 30 units of fresh frozen plasma (FFP), obtained by processing single donor whole blood. We have pooled two units of fresh plasma, identical ABO blood groups, and by dividing them got 15 pairs of fresh frozen plasma (30 units). One pair included a test unit, which will be photo-inactivated (FP) and a control unit (KP). We added 35 ml of riboflavin (500 µM) in the treated unit (FP) and illuminated it with UV lihgt (6.24 J/ml) on the Mirasol Illuminator (Caridian BCT Biotechnologies; USA). In order to obtain equal dilution, we added 35 ml of saline into the control unit. After illumination, we took samples (1.5 ml aliquots) from FP and KP and froze them at -80 °C. Control and treated plasma bags were frozen simultaneously at -30 °C. After one month, samples were thawed and concentration of F VIII in FP and KP units were compared. Results: Median value FVIII in the treated plasma was 0.84 IE/ml (0.59–0.92 IE/ml). Median percent recovery was 68 % (59–78 %). Average inactivation time was 3 minutes and 9 seconds ± 22 seconds . Conclusion: The study results showed that the pathogen reduction process using Mirasol technology affects the concentration of F VIII in plasma. FVIII concentration in the treated units is consistent with the recommendations and is comparable to the concentration of FVIII after treatment with other inactivation methods.
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