Main Properties of the THERAFLEX MB-Plasma System for Pathogen Reduction.

Methylene blue (MB) treated plasma has been in clinical use for 18 years. The current THERAFLEX MB-Plasma has a number of improved features compared with the original Springe methodology. This overview embodies: the biochemical characteristics of MB, the mechanism of the technology, toxicology, pathogen reduction capacity, current position in clinical setting and status within Europe. The THERAFLEX MB (TMB) procedure is a robust, well standardised system lending itself to transfusion setting and meets the current guidelines. The pathogen kill power of the TMB system, like the other available technologies, is not limitless, probably in order of 6 log for most enveloped viruses and considerably less for non-enveloped ones. It does not induce either new antigen or grossly reducing the function and life span of active principle in fresh frozen plasma (FFP). The removal of the residual MB at the end of the process has the beneficial effect of reducing potential toxic impacts. Clinical haemovigilance data, so far, indicate that cell-free MB plasma is effective in all therapeutic setting requiring FFP, besides inconsistent thrombotic thrombocytopenia purpura data, without serious side-effects or toxicity. The current system is in continuous improvement e.g. regarding virus reduction range, illumination device, software used, and process integration in the blood bank setting.

Clinical and epidemiological aspects of human bocavirus infection.

Human bocavirus was recently described as a novel member of the Parvoviridae to infect humans. Based on accumulating clinical and epidemiological data the virus is currently being associated with respiratory infections in young children and infants and is furthermore discussed as causative agent of gastrointestinal illness.

Humoral immune response against human bocavirus VP2 virus-like particles.

Human bocavirus (HBoV) was recently detected in samples from children and infants with infections of the respiratory tract. Here we analyze the prevalence of IgG and IgM antibodies against HBoV virus-like VP2 particles in healthy adult blood donors and children using a newly established standardized enzyme-linked immunosorbent assay. Virus-specific IgG antibodies were frequently detected in infants with active viremia and respiratory illness (10/24, 42%) and in young children without detectable HBoV genomes in their blood (27/52, 52%). In sera obtained from healthy adults, ubiquitous VP2-specific antibodies were found in 280/299 (94%) cases. HBoV-specific IgM antibodies were detected in 10/24 (42%) of sera samples obtained from HBoV DNA-positive children, and in 6/24 (25%) the sera displayed equivocal responses. In contrast, VP2-specific IgM was not detectable in samples obtained from 52 children without detectable amounts of HBoV genomes in their blood. Only 2/299 sera samples from healthy adult blood donors were found to be IgM-positive (1%), and equivocal IgM responses were observed in 9/299 (3%) individuals. In conclusion, a high IgG seroprevalence of HBoV in the adult population was observed, whereas the presence of virus-specific IgM was associated with viremia. These data show that ELISA test systems for the detection of HBoV-specific antibodies are a valuable tool for serological diagnosis of this new emerging pathogen.

Antibody reactivity of a standardized human serum protein solution against a spectrum of microbial pathogens and toxins: comparison with fresh frozen plasma.

In this study, we compared a standardized solution of human serum protein (HSP) and fresh frozen plasma (FFP) with regard to the antibody specificity against a number of microbial pathogens and some important pathogenicity factors of bacterial pathogens. Due to the clinical use of HSP and FFP for therapeutical plasma exchange, we have chosen a spectrum of microbial pathogens for serological analysis that is critical in clinical settings. With the enzyme-linked immunosorbent assay technique, we could show that HSP contains marked IgG antibody reactivity against antigens of Escherichia coli, Campylobacter jejuni, Enterobacter sakazakii, Proteus mirabilis, Pseudomonas aeruginosa, Klebsiella pneumoniae, Staphylococcus aureus, S. epidermidis, Streptococcus pneumoniae, Enterococcus faecalis, Chlamydia pneumoniae, and Candida albicans. Although no IgM antibodies against the pathogens tested could be detected in HSP, moderate IgA reactivity was found against 4 of 12 microbial antigens. Immunoblot analysis demonstrated specific IgA and IgG responses against the endoproteinase Glu-C and the superantigens enterotoxin A and B of S. aureus, the IgA-protease of Neisseria gonorrhoeae, and Shiga toxin 2 of enterohemorrhagic E. coli. By using 3 different HSP batches in parallel, we could demonstrate antibody reactivity against important microbial pathogens and toxins. This antibody profile is essentially more homogeneous than that of 3 batches of FFP.