Pathogen inactivation efficacy of Mirasol PRT System and Intercept Blood System for non-leucoreduced platelet-rich plasma-derived platelets suspended in plasma

摘要

Background and Objectives This study was conducted to evaluate the efficacy of pathogen inactivation (PI) in non-leucoreduced platelet-rich plasma-derived platelets suspended in plasma using the Mirasol PRT System and the Intercept Blood System. Methods Platelets were pooled using the Acrodose PL system and separated into two aliquots for Mirasol and Intercept treatment. Four replicates of each viral strain were used for the evaluation. For bacteria, both low-titre (45-152 CFU/ unit) inoculation and high-titre (7-34-10-18 log CFU/unit) inoculation with two replicates for each bacterial strain were used. Platelets with non-detectable bacterial growth and platelets inoculated with a low titre were stored for 5 days, and culture was performed with the BacT/ALERT system. Results The inactivation efficacy expressed as log reduction for Mirasol and Intercept systems for viruses was as follows: human immunodeficiency virus 1, >4-19 vs. >4-23; bovine viral diarrhoea virus, 1-83 vs. >603; pseudorabies virus, 2-73 vs. >5-20; hepatitis A virus, 0-62 vs. 0-76; and porcine parvovirus, 0-28 vs. 0-38. The inactivation efficacy for bacteria was as follows: Escherichia coli, 5-45 vs. >9-22; Staphylococcus aureus, 4-26 vs. >10-ll; and Bacillus subtilis, 5-09 vs. >7-74. Postinactivation bacterial growth in platelets inoculated with a low titre of S. aureus or B. subtilis was detected only with Mirasol. Conclusion Pathogen inactivation efficacy of Intercept for enveloped viruses was found to be satisfactory. Mirasol showed satisfactory inactivation efficacy for HIV-1 only. The two selected non-enveloped viruses were not inactivated by both systems. Inactivation efficacy of Intercept was more robust for all bacteria tested at high or low titres.