Rapid test to detect bacteria in red cell concentrates.

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 red blood cells. 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 red bloods cell units for transfusion. These antibodies have been incorporated in both ELISA and lateral-flow assays to detect a broad array of bacteria with high levels of specificity and sensitivity. In this Phase I project, Verax will verify the feasibility of a rapid sensitive and easy-to-use bacterial detection assay that is practical for the purpose of routine screening of red cell units in hospital transfusion and blood centers. This will lead to a Phase II proposal to commercially develop and validate the 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.