A comparison of methods of pathogen inactivation of FFP

Abstract

Introduction: Current methods for pathogen inactivation of plasma involve four major processes using solvent-detergent (SD), methylene blue (MB), amotosalen and riboflavin as additives. Three of these methods involve the use of visible or ultraviolet light.

Methods: A comparison of the four methods was made using publications in Medline, Pubmed, Embase and Biosis to obtain data on the logistics of use, the quality of the plasma proteins and the effectiveness of pathogen inactivation.

Results: Three of the methods, MB, amotosalen and riboflavin, are designed for use in a blood bank; the SD method is generally applied at a centralized manufacturing centre and involves large plasma pools. All methods result in a reduction in protein values with the per cent retention of FVIII activity in the range of 67-78% and fibrinogen of 65-84%. Protein S and alpha(2)-antiplasmin are lower following solvent-detergent treatment. Alterations in fibrinogen structure have been reported with methylene blue.

Discussion: Three of the methods are designed for small volume use in a blood bank. All four methods have some effect on the coagulant proteins; however, the final concentrations are within regulated limits. While there is variability in the effectiveness against pathogens, direct comparison is difficult because of the methodologies used. Nonetheless, all are effective in inactivating HIV and other lipid-enveloped pathogens. Clinical studies on the effectiveness of these products are surprisingly sparse, and no randomized clinical trials have yet been performed with amotosalen or riboflavin plasmas.