Evaluation of a new apheresis system for the collection of leukoreduced single-donor platelets.

BACKGROUND

The Fresenius COM.TEC cell separator is a new device for producing white cell concentrates (WBCs) and leukoreduced single-donor platelet concentrates (SDPs) and performing therapeutic cytapheresis and plasmapheresis that might replace the Fresenius systems AS104 and AS.TEC 204. This novel system's performance was evaluated for producing leukoreduced SDPs.

STUDY DESIGN AND METHODS

In an investigational phase, each of 200 donors underwent plateletpheresis with the AS.TEC 204 and the COM.TEC systems. The collection efficiency (CE) and WBC contamination of the different techniques were compared. After some hard- and software modifications, the system was evaluated in an additional 800 procedures in the confirmatory phase.

RESULTS

In the investigational phase, the CE of the COM.TEC device was increased significantly in comparison to the AS.TEC 204 device's CE (by 45 +/- 32% when collecting 1 unit of platelets [PLTs] and 1 unit of fresh-frozen plasma and by 43 +/- 42% when collecting only 1 unit of PLTs). Although all AS.TEC products proved to be leukoreduced, 2 percent of the COM.TEC procedures led to PLT concentrates containing more than 1 x 10(6) WBCs. In the confirmatory phase, all 1300 products from 800 COM.TEC procedures proved to be leukoreduced. Furthermore, the CE increased significantly from 53.5 +/- 4.6 percent in the investigational phase to 55.5 +/- 4.9 percent (p < 0.001) in the confirmatory phase.

CONCLUSIONS

These data suggest that the new COM.TEC system offers a significantly and importantly improved CE in plateletpheresis procedures in comparison to the AS.TEC system. In the final version, the PLT products collected with this system fulfill the most stringent criteria for leukoreduced PLTs. This aim was achieved without additional filtration steps and thus without filtration-related PLT loss.