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Abstract

Grant Number:	2R44HL069620-02
PI Name:	HALL, JEFFREY A.
PI Email:	jhall@veraxbiomedical.com
PI Title:
Project Title:	Rapid test to detect bacteria in platelet concentrates.

Abstract: DESCRIPTION (provided by applicant): Verax Biomedical Inc. proposes to develop a rapid, accurate, cost-effective screening test to detect a broad array of bacterial contaminants in stored human platelet preparations. The risk of bacterial contamination is approximately 1 per 2,000 donations, which makes it the single greatest infectious risk in transfusion medicine today. Currently, no inexpensive or rapid broad detection test is available commercially. Verax has identified a panel of antibodies, which selectively bind to conserved structures on the surface of Gram-positive or Gram-negative bacteria. These binding agents demonstrate cross-genera and cross-species binding affinities for the bacteria that are known to contaminate human platelet units for transfusion. These antibodies have been incorporated into both ELISA and lateral-flow assays to detect a broad array of bacteria with high levels of sensitivity and specificity. In this Phase II project, Verax will commercially develop and validate the lateral-flow assay for regulatory submission. The successful development of Verax's Bacterial Class Detection technology will improve the availability and safety of the human blood supply and will have broad potential for bacterial detection applications in human diagnostic, food testing, environmental testing and other research uses.

Thesaurus Terms:
antibacterial antibody, blood bank /supply contamination, communicable disease control, communicable disease diagnosis, diagnosis design /evaluation, immunologic assay /test, platelet, serology /serodiagnosis
bacterial antigen, diagnosis quality /standard
clinical research, enzyme linked immunosorbent assay, human tissue

Institution:	VERAX BIOMEDICAL, INC.
	3-E GILL ST
	WOBURN, MA 01801
Fiscal Year:	2003
Department:
Project Start:	01-APR-2003
Project End:	31-MAR-2005
ICD:	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
IRG:	ZRG1

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