Viral safety of solvent/detergent‐treated plasma

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Abstract
BACKGROUND: Pooling of plasma donations increases the risk for blood‐borne infections. In solvent/detergent (SD)‐treated plasma, lipid‐enveloped viruses are efficiently inactivated. This method, however, does not affect non‐lipid‐enveloped viruses. The current study investigated the viral safety of SD‐treated plasma (Octaplas) and paid particular attention to the transmission of non‐lipid‐enveloped viruses. STUDY DESIGN AND METHODS: The study comprised 343 adults undergoing cardiac surgery. Follow‐up was performed 6 to 12 months and 2 years after operation. The sera were tested for hepatitis B surface antigen and specific antibodies against hepatitis A, B, and C; cyto‐megalovirus; HIV, human T‐lymphotropic virus types I and II; and human parvovirus B19 (B19). A total of 25 batches of SD‐treated plasma prepared from Norwegian plasma were used. All batches were tested for hepatitis A virus and B19 by nucleic acid amplification testing and investigated for neutralizing antibodies directed against these viruses. RESULTS: In patients who received SD‐treated plasma, B19 seroconversion occurred at a rate similar to that in nontransfused patients. No other seroconversions could be ascribed to the transfusion of SD‐treated plasma. All 25 SD‐treated plasma batches contained neutralizing antibodies against hepatitis A virus and B19. In nucleic amplification testing, all SD‐treated plasma batches tested positive for B19, while five demonstrated borderline reactions for hepatitis A virus. CONCLUSION: Transfusion of SD‐treated plasma was found to be safe with regard to lipid‐enveloped viruses. Immune antibodies neutralize viral particles in plasma and are of importance in avoiding clinical disease with the non‐lipid‐enveloped hepatitis A virus and B19.