GODX INC — Department of Health and Human Services SBIR Phase I: NCATS

Description

Rapid and Simple Paper Strip Test for the Multiplexed Detection of Gastrointestinal Pathogens at the Point of Need GoDx Product Summary This Phase project will demonstrate the feasibility of developing a paper strip device for rapid andlt minutes and simple multiplexed detection of a gastrointestinal GI pathogens that cause diarrheal disease The pathogens include C Difficile for the U S and the pathogens Cryptosporidium Giardia lamblia Rotavirus Shigella Enterotoxigenic Escherichia coli ETEC and Enteroaggregative Escherichia coli EAggEC commonly found in the developing world A highly innovative simple and low cost sample preparation and concentration will be carried out using hollow silica microspheres that efficiently capture total nucleic acids and floats to the air liquid interface for collection The captured nucleic acids will be released onto the center of a novel star shaped lateral flow device for multiplexed detection of pathogens Analytical validation will be conducted including assessments of reproducibility CV andlt sensitivity andgt specificity andgt limit of detection cells g stool and dynamic range logs on pathogen spiked in samples or pathogen infected samples The accuracy of the test will be benchmarked using current gold standard diagnostic methods such as microscopy culture PCR and ELISA kit and the FDA approved Luminex Gastrointestinal Pathogen Panel GPP bead detection and Biofire Biomerieux GI Panel Rapid and Simple Paper Strip Test for the Multiplexed Detection of Gastrointestinal Pathogens at the Point of Need GoDx Project Narrative Diarrheal disease kills million people worldwide ever year mostly children in the developing world in resource limited settings An effective low cost test to identify the pathogens causing persistent diarrhea may help guide prompt and appropriate treatment and reduce antimicrobial resistance from antibiotic overuse We are developing a simple rapid and sensitive paper strip test to identify gastrointestinal pathogens that cause diarrheal disease without the use of expensive instrumentation at the point of need