Biodetection Instruments, Inc — Department of Health and Human Services SBIR Phase I: FDA

Description

DESCRIPTION provided by applicant This SBIR Phase I project seeks to develop a proof of concept for an integrated system for rapid screening of foodborne pathogens in a sample in answer out format The proposed system is based on integration of patented sample preparation technology and patent pending self contained microfluidic assay cartridge technology The Phase I study will focus on detection of Salmonella in ready to eat RTE foods with S enterica serovar Typhimurium as a model pathogen The primary Phase I goal is to achieve a detection limit of CFU g for specific detection of the target pathogen in less than h Although the United States enjoys one of the safest food supplies in the world contamination of food products by microbial pathogens remains a major concern of our society It is estimated that contaminated food causes million illnesses hospitalizations and deaths in the U S each year Nontyphoidal Salmonella e g S typhimurium is one of the top five pathogens causing foodborne illnesses in the United States To prevent the introduction of contaminated food products into the food supply chain monitoring of foodborne pathogens is a critical control point Unfortunately currently detection of bacterial pathogens in food and other matrices still heavily relies on culture methods which are extremely time consuming often taking up to hours or more Rapid and sensitive detection of bacterial pathogens in food products will help prevent foodborne infections and thus help protect the public health It will also help reduce medical costs and productivity losses The proposed automated system will have the potential to address the limitations of current microbial detection methods e g laboriousness and tediousness culture methods complexity and high skill requirement PCR lack of sensitivity lateral flow immuno strip tests or specificity conventional ATP bioluminescence Eventually the test will be fully automated requiring minimal operator training If successfully developed the proposed assay will address the need for rapid screening of Salmonella spp in RTE and other foods Results will be available quickly enough to pull contaminated product while still at the processing facility thereby avoiding consumer exposure and costly recalls that result in negative publicity and possible lawsuits for producers The proposed technology will be applicable to other foodborne pathogens opening the door to wider commercial utility PUBLIC HEALTH RELEVANCE Although the United States enjoys one of the safest food supplies in the world contamination of food products by microbial pathogens remains a major concern of our society Rapid and sensitive detection of bacterial pathogens in food products will help prevent foodborne infections and thus help protect the public health