Safety profile of THERAFLEX MB-Plasma
When exposed to visible light, MB is higly effective in inactivating lipid-enveloped viruses such as HIV, HBV, HCV and the newly emergent West Nile Virus, non-enveloped viruses such as Parvovirus B19 and bacteria.
Inactivation of enveloped viruses
Inactivation of non-enveloped viruses
A final virus content below he detection limit implies a depletion at least as equivalent as the initial virus content.
Reduction of Parasites
Reduction of cells (including intracellular viruses)
Plasma filtration not only decreases transfusion reactions and HLA alloimmunisation but also provides the benefit of removing cell-asociated pathogens such as cytomegalovirus (CMV) and human T-cell lymphotropic viruses (HTLV) I and II.
Reduction of transfusion-relevant bacteria or bacterial spores due to the THERAFLEX MB-Plasma procedure filtration steps
Bacterial reduction is achieved after both filtration steps (Plasma filtration with the PLAS4 filter ad MB-treated plasma filtration with the Blueflex filter) in the treated plasma.
The overall reduction capacity of the THERAFLEX MB-Plasma system is sufficient to prevent transfusion-transmitted bacterial infections, taking into account the concentration of bacteria normally present in contamined terapeutic plasma.
21) N. Gironés, J. L. Bueno, J. Carrión, M. Fresno, E. Castro The efficacy of photochemical treatment with methylene blue and light for the reduction of Trypanosoma cruzi in infected plasma. Vox Sanguinis (2006) 91, 285–291.
22) Gravemann, U., Reichenberg, S., Sumian, C., Lambrecht, B., and Seltsam, A. 2012. Elimination of Becteria from Fresh Frozen Plasma with the THERAFLEX MB-Plasma System. Transfusion 52:10A-284A (Abstr.)
23) Gravemann, U., Reichenberg, S., Sumian, C., and Seltsam, A. 2013. The Blueflex filter of the THERAFLEX MB-Plasma system (Macopharma) efficiently removes different bacteria species from therapeutic plasma.) Vox sanguinis 105 (Suppl. 1), 65-299 (Abstr.)