Preparation of cryoprecipitate from riboflavin and UV light-treated plasma

摘要

Background and objectives: The Mirasol? pathogen reduction technology system for plasma is based on a riboflavin and UV light treatment process resulting in pathogen inactivation due to irreversible, photochemically induced damage of nucleic acids. This study was undertaken to evaluate the possibility of making pathogen reduced cryoprecipitate from riboflavin and UV light- treated plasma that meets the quality requirements specified by UK and European guidelines for untreated cryoprecipitate. Materials and methods: Cryoprecipitate was made from riboflavin and UV light-treated plasma. Plasma units were thawed over a 20. h period at 4°C, and variable centrifugation settings (from 654. g for 2. min to 5316. g for 6. min) were applied to identify the optimal centrifugation condition. Plasma proteins in cryoprecipitate units were characterized on a STA Compact, Diagnostica STAGO and Siemens BCS analyzer. Results: Neither the centrifugation speed or time appeared to have an effect on the quality of the final cryoprecipitate product; however the initial solubilization of the cryoprecipitate product was found to be easier at the lower centrifugation setting (654. g for 2. min). Cryoprecipitate units prepared from Mirasol-treated plasma demonstrated protein levels that were less than levels in untreated products, but were on average 93. IU/unit, 262. mg/unit and 250. IU/unit for FVIII, fibrinogen and von Willebrand ristocetin cofactor activity, respectively. Conclusion: Cryoprecipitate products prepared from Mirasol-treated plasma using a centrifugation method contain levels of fibrinogen, FVIII and von Willebrand ristocetin cofactor activity, that meet both the European and UK guidelines for untreated cryoprecipitate. Flexibility in centrifugation conditions should allow blood banks to use their established centrifugation settings to make cryoprecipitate from Mirasol-treated plasma.