Rapid Bacterial Detection in Platelet Concentrates

DESCRIPTION (provided by applicant): A rapid detection system can be readily developed to prevent bacterial contamination in platelet concentrates that are intended for transfusion. Bacteria contamination of platelet concentrates intended for transfusion, represents the most frequent transfusion-associated infectious risk. Bacterial contamination levels as low as 102 to 103 CFU/ml have been associated with fever and positive blood culture. Transfusion-related bacterial contamination (TABC) is a serious health risk that accounts for 10 percent of transfusionasociated deaths reported in the USA. The problem is compounded with stored platelets as room temperature and high dextrose in the medium obviously promote the growth of bacteria. In March of 2004 the American Association of Blood Banks issued a directive for the detection of bacterial contamination of platelet concentrates. A innovative, rapid low cost method has been developed in which bacterial contamination of platelet concentrates can be measured by a fully automated, microprocessor driven system that has been designed for rapid detection of bacterial contamination of platelet concentrates. Utilizing a novel method of bacterial isolation and microfluidics, a chemiluminescent based detection system will provide a bacterjal load of the platelet product. Validation and verification of device performance will be measured evaluating bacterial load of 7-10 day outdated platelets, as well as validation and verification performed by inoculation of apheresis platelets with the 14 FDA specified bacterial species required for device approval. Commercialization: The rapid detection system has substantial commercialization potential in that it can be implemented into screening of all platelet and blood products meant for transfusion in the United States and worldwide. It is anticipated that the rapid bacterial detection system could economically be implemented into all apheresis collection systems as well as random donor platelet collection operations. The objective is to reduce infectious risk associated with transfusion of platelets. The business opportunity in the US alone is to screen 9,000,000 platelet transfusions at an affordable cost to non-porfit organizational blood banks.