REAL-TIME DETECTION OF BACTERIA IN PLATELET CONCENTRATES

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DESCRIPTION (Provided by applicant): BCR Diagnostics, Inc. (BCR) proposes to demonstrate the feasibility of adapting its LEXSAS (Label-free Exponential Signal-Amplification System) technology for real-time bacteriologic analysis of blood products intended for transfusion. The LEXSAS technology is unique in that it uses spores as ultrasensitive nanodevices capable of emitting fluorescent light signals when encountering single bacterial cells. This extraordinary ability is due to integrated spore mechanisms for sensing/transducing/amplifying discrete biomolecular signals in the milieu. Based on theoretical considerations and preliminary studies, BCR expects that the biosensor will have the following specifications: ability to detect a single bacterium; ability to yield quantitative results in less than 60 minutes; minimal sample preparation; no labeling reagents (such as fluorescent, radioisotopic or enzymatic reporter molecules) are required; linear detection response over a wide dynamic range of one to 10E6 bacteria per ml; single use (disposable), low manufacturing cost; and applicability to automated high-throughput operations. A real-time bacteriological biosensor should have a major impact not only in making transfusions safer for patients, but also in the financial aspects of blood banking. PROPOSED COMMERCIAL APPLICATION: BCR's real-time bacteriologic biosaensor would have a critical impact in public health and other major industries now relying on culture-based testing that usually requires 16-48 hours for completion. Potential commercial applications of the technology include: (1) clinical diagnostics; (2) bioterrorism defense; (3) screening food and beverages; (4) environmental monitoring (air and water); (5) sterility testing; and (6) screening blood products intended for transfusion.