CELLBAE INC. — Department of Agriculture SBIR Phase I: 8.5

Description

Early rapid and accurate detection of foodborne pathogens is important for outbreak preventionmaintaining food safety along the supply chain and ensuring that food consignments are notsubjected to unnecessary delays. Confirmatory culture-based methods or technologies (e.g.polymerase chain reaction and mass spectrometry) are labor-intensive have long turnaround time(1-5 days) and require expensive instrumentation. This is too slow and expensive for the foodindustry for mass screening. Lateral flow rapid test kits (RTKs) are rapid (15 min runtime)inexpensive user-friendly and the results can be read directly by the naked eye making thempromising for on-site testing methods. However conventional RTKs have inherent sensitivitylimitations due to the reliance on gold nanoparticles (Au NPs) or latex beads as signal labels.We have developed a RTK platform with a built-in enzymatic amplification mechanism forultrasensitive (10-1000 times more sensitive) detection of foodborne pathogens E. coli O157:H7and Salmonella Enteritidis.We have screened and selected antibody pairs for these two RTKs withexcellent detection limit (1000 CFU/mL) and specificity. Herein we will validate the RTKs with alarge panel (> 20 strains each) of reference bacteria materials spiked into relevant food matrices andculture media. We will also conduct accelerated stability test to validate the RTK productionenzyme-antibody conjugation and stability formuation protocols. The sensitivity and specificitydata from this Phase I project can be used towards AOAC certification (to be pursued in a Phase IIproject) which will allow us to commercialize and market the RTKs.