Methods for Routine Bacterial Screening of Donated Blood

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DESCRIPTION (provided by applicant): Bacterial contamination of transfused blood products is a well-recognized source of sepsis and remains a serious concern to blood bank and transfusion center personnel. Despite these concerns there currently exists no widely accepted, practical and reliable method for routinely screening banked blood for potentially harmful levels of bacterial contamination. The development of such a method(s) would greatly reduce the risk of bacterial sepsis due to blood transfusions and further ensure the overall safety of the nation's blood supply. Physical Sciences Inc. proposes, in conjunction with our R&D collaborators, to develop and demonstrate two methodologies for the rapid and routine screening of banked blood products (i.e., red blood cells and platelets) for potentially dangerous levels of bacterial contamination. The proposed independent, but potentially complementary, approaches, already shown to be feasible, entail: 1) a method based on visible/NIR spectroscopy to directly monitor the bagged product (no aliquots of the blood need be withdrawn) for harmful levels of bacterial growth, and 2) an automated epifluorescence microscopy-based technique to assay a small sample of the blood product for bacteria. The Phase II effort will design and develop clinical prototype blood product screening instruments based on these technologies and extensively test them for their sensitivity, specificity and ease of use for bacterial detection in red blood cells (RBC's) and platelets. PROPOSED COMMERCIAL APPLICATION: A rapid, reliable and widely accepted method(s) to routinely screen donated blood products for potentially hazardous bacterial contamination prior to their transfusion would make an important contribution to the safety of the nation's blood supply. Once demonstrated to be reliable and cost-effective, the proposed methodology and associated instrumentation should have significant commercial potential. Effective point-of --use bacterial testing of platelets may also allow platelet shelf life to be extended from 5 to 7 days, thus increasing nation's platelet supply dramatically.