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Abstract

Grant Number:	2R44HL070360-02
PI Name:	ROTMAN, BORIS
PI Email:	rotman@bcrbiotech.com
PI Title:
Project Title:	REAL TIME DETECTION OF BACTERIA IN PLATELET CONCENTRATES

Abstract: DESCRIPTION (provided by applicant): Bacterial contamination of blood products is currently a major problem in transfusion medicine and a leading cause of transfusion-related deaths. Platelets are particularly susceptible to contamination because they are stored at room temperature. BCR Diagnostics, Inc. (BCR) has developed a novel biosensor platform for detecting low levels of bacteria in real time (i.e., about 2 minutes). During Phase I, BCR has demonstrated the feasibility of adapting its technology to developing a low-cost biosensor for detecting bacteria in platelet concentrates shortly before transfusions. BCR's biosensor is based on the LEXSAS (Label-free Exponential Signal-Amplification System), a unique methodology using spores as ultrasensitive nanodetectors capable of emitting fluorescent light signals when encountering single bacterial cells. For Phase II, BCR proposes: 1. To construct a marketable biosensor prototype that will extend the system's sensitivity to single bacterial cells. 2. To use the prototype for a study designed to obtain experimental data that will meet the Food and Drug Administration (FDA) requirements for premarket approval of the biosensor. The study will consist of three major tasks: 1. To test, optimize, and standardize the biosensor prototype in terms of sensitivity, completion time, analysis reproducibility, and dynamic range. 2. To use the prototype for experiments designed to obtain a "Data Package" to be submitted to the FDA. This task includes experiments that will show the accuracy (sensitivity and specificity) of the biosensor for identifying platelet concentrates spiked with a panel of about 13 different bacterial strains from a list provided by the FDA. 3. To do a double-blind study to validate the commercial usefulness of the biosensor. Other potential applications of the bacteriologic biosensor include: diagnostics, environmental surveillance, food and beverage monitoring, and sterility testing.

Thesaurus Terms:
bacteria, bacterial cytopathogenic effect, biosensor, blood bank /supply contamination, communicable disease control, communicable disease diagnosis, diagnosis design /evaluation
aminopeptidase, bacteria infection mechanism, biomedical automation, consumable /disposable biomedical equipment, high throughput technology, platelet, time resolved data
clinical research, human tissue

Institution:	BCR DIAGNOSTICS
	1062 EAST SHORE RD
	JAMESTOWN, RI 02835
Fiscal Year:	2003
Department:
Project Start:	15-APR-2002
Project End:	30-JUN-2005
ICD:	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
IRG:	ZRG1

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