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Updated: Jun 12, 2026
Preparation and Pathogen Inactivation of Double Dose Buffy Coat Platelet Products using the INTERCEPT Blood System
Published on: December 7, 2012
In vitro and in vivo evaluation of apheresis platelets stored for 5 days in 65% platelet additive solution/35% plasma
Ralph R Vassallo1, John W Adamson, Jerome L Gottschall
1American Red Cross Blood Services, Penn-Jersey Region, Philadelphia, Pennsylvania 19123, USA. usa.redcross.org
Background:
In the United States, apheresis platelets (PLTs) are suspended in autologous plasma. PLT additive solutions, long used in Europe, decrease recipient allergic reactions and may reduce the risk of transfusion-related acute lung injury. We evaluated Amicus-collected PLTs stored in platelet additive solution (PAS) III (InterSol) for 5 days.
Study Design And Methods:
In Study 1, 71 subjects donated two products on a single day-one each stored in 100% plasma or 65% PAS III/35% plasma. Products underwent standard in vitro testing on Days 1 and 5. In Study 2, 43 additional subjects provided Amicus products stored for 5 days in 65% PAS III/35% plasma for in vivo radiolabeled recovery and survival determinations. The effect of approximately 2500cGy Day 1 gamma irradiation was evaluated in a subset of products.
Results:
PAS III PLTs (n=70) had a median Day 5 pH(22°C) of 7.2 (lower 95%, 95% tolerance limit, 6.9). Mean Day 5 recovery and survival of radiolabeled PAS III PLTs (n=33) were, respectively, 80.5 and 72.1%, of fresh autologous PLTs. With 95% confidence, these values were at least 66% of fresh PLT recovery and 58% of survival. All in vitro variables remained within ranges seen in licensed products for irradiated and nonirradiated PAS III PLTs.
Conclusion:
Leukoreduced Amicus PLTs stored in 65% PAS III/35% plasma in PL-2410 containers maintained pH ≥6.9 throughout 5 days' storage. Radiolabeled PLT recovery and survival values met US Food and Drug Administration statistical criteria. Gamma-irradiated PAS III PLTs demonstrated no significant adverse effects due to irradiation in in vitro testing.
