Rapid, Portable, Point-of-Care Carbapenem Resistant Acinetobacter Colonization Screening Diagnostic

Phase I SBIR proposals will be accepted. Fast-track proposals will not be accepted. Phase I clinical trials will not be accepted. Number of anticipated awards: 1 Budget (total costs): Phase I up to $243,500 for up to 6 months; Phase II of up to $2,045,816 and a Phase II duration of up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Background Carbapenem-resistant Acinetobacter baumannii (CRAB) is a multidrug resistant Gram-negative bacterium that causes serious and difficult to treat infections in the blood, urinary tract, lungs, wounds, and other anatomic sites. CRAB infections don't respond to common antibiotics and this resistance is often conferred through carbapenemase-encoding genes such as NDM, OXA-23 and OXA24. Importantly, CRAB can also asymptomatically colonize the skin and other body parts of patients, which, if left undetected, leads to increased environmental contamination and rapid transmission within the healthcare setting. For these reasons, CRAB colonization screening is performed to inform infection prevention interventions in healthcare settings, such as Transmission-Based Precautions. Rapid identification of CRAB is essential for the timely implementation of infection control measures to prevent additional transmission events. CRAB colonization screening currently requires that primary specimens (e.g., skin swabs) are transported to a CLIA-certified laboratory for testing. This dependency on specialized laboratory resources delays the time to result and more broadly limits capacity for CRAB screening. A rapid point-of-care (POC) test that can be performed in a CLIA-waived environment would therefore increase the national capacity for CRAB screening and improve the timely implementation of appropriate infection prevention interventions. The goal of this project is to further advance the technology and provide options to test primary screening samples directly in the U.S., without the need to recover an isolate or access a high-complexity laboratory.