In vitro evaluation of COM.TEC apheresis platelet concentrates using a preparation set and pathogen inactivation over a storage period of five days

Abstract

The aim of the present study was to evaluate in vitro data on platelets collected by apheresis, processed on a preparation set followed by photochemical treatment (PCT). Fifteen single-donor platelet concentrates (PCs) were collected by apheresis (COM.TEC blood cell separator, Fresenius, Bad Homburg, Germany). The platelets were transferred to the preparation set and plasma was removed after centrifugation to resuspend the platelets in approximately 37% plasma and 63% platelet additive solution InterSol. PCT was done by exposing the platelets to amotosalen HCl followed by illumination with ultraviolet light. Blood cell counts and in vitro PLT function were measured up to 5 days. An average of 3.44 +/- 0.28 x 10(11) platelets were collected in a product volume of 351 +/- 21 mL. Plasma removal resulted in a mean platelet loss of 7.8%. After PCT, a progressive decrease in platelet function was observed. LDH level rose through storage (171 +/- 81 U/L) to levels approximating LDH levels observed post-collection (180 +/- 103 U/L). There was a gradual decrease of the platelets to respond to hypotonic shock response from 90 +/- 9 % post-plasma reduction to 48 +/- 16% at day 5. All PLT units met the European requirements for leukoreduction and the pH limit of 6.8 up to day 5 post-collection. The new preparation set was capable of producing platelet units meeting the requirements for PCT. Despite differences observed in in vitro platelet function parameters, PLTs at storage day 5 fit the German and European guidelines.