Non-mobilized leukopaks are collected under an IRB-approved protocol from normal healthy individuals and qualified in accordance with current regulations and requirements for donors of transfusable blood components. This includes screening with the Uniform Donor History Questionnaire that was developed by the AABB and accepted by the Food and Drug Administration for screening of donors of transfusable blood components.

All donors are prescreened for evidence of transfusion-transmissible infectious diseases with the standard panel of tests used to screen blood products for transfusion acceptability, which include HBV, HCV, HIV, HTLV, WNV, Trypanosoma cruzi, and Syphilis. Testing for exposure to Babesia microti is performed for donors in selected geographic regions in accordance with FDA recommendations.

Leukopaks are collected in our FDA-registered collection centers by leukapheresis. This mononuclear cell-rich leukapheresis product is extracted using the Spectra Optia® Apheresis System directly into the collection bag containing ACD-A anticoagulant.