2003 Volume 12 Issue 3-4 Pages 58-61
The physical and chemical treatments for elimination of pathogens from human plasma fraction (HPF) are very important for transfusion therapy. In this study, we evaluated the safety by the sterile filtration, virus removal filtration, heat inactivation and alcohol treatment of human albumin fraction containing Babesia microti. Following treatments, mice were challenged infection to establish a model for detection of B. microti in HPF. We chose the same methods to process the globulin and albumin fractions, as with the treatments of the samples. As a result, we did not detect parasites in mice inoculated with all treated samples when Giemsa-stained thin blood smears from the challenged mice were examined for 51 days. However, by immunofluorescent antibody assay, we found some parasites in the sample which had been filtrated by a sterility filter (0.2µm). This suggests that B. microti might be able to pass through the routinely employed sterile filter, and babesiosis might occur when the manufacturing process includes the sterile filtration only. It is suggested that blood plasma products which have been introduced with the multiple processes of virus removal and/or inactivation such as alcohol fractionation, pasturization, chemical treatment, virus removal filtration to their manufacturing process, might be safe against protozoa infections.