Low cost point-of-care diagnostic to address community vitamin D health disparities

PROJECT SUMMARYEpidemiologic and randomized clinical studies suggest that low vitamin D levels are associated with decreased bone mineral density and increased fracture riskAdditionallyvitamin D plays a major role in various metabolic processes and deficiency has been implicated in childhood ricketsosteoporosistype II diabetesand a variety of cancersSincevitamin D levels have been decreasing across the U Spopulationby approximatelyThere is a significant disparity in vitamin D status among non Hispanic BlacksMexican Americansand non Hispanic whites in the United Stateswith non Hispanic Blacks having the highest prevalence of vitamin D deficiencyandltng mlfollowed by Mexican AmericansBoth groups also have a higher prevalence of vitamin D inadequacyng mlthan non Hispanic whitesRandomized clinical trials have shown that adequate vitamin D intake through dietary supplementation in populations at risk for nutritional deficiency can prevent fragility fractures and may improve metabolic disease outcomeSupplementation is thus an easy and inexpensive mode of treatmenthoweverthere does not currently exist a point of carecost effective method of measuring a patient s vitamin D statusSerum vitamin D is measured clinically using platebased enzyme linked immunosorbent assayELISAtestswhich can take one to three hours and require a laboratory settingBreviTest Technologies LLC is developing a portable analyzer to perform a rapidquantitative ELISA test within aminute run timeThe sample is loaded into a microfluidics cartridgeand an automated mechanism controls the movement of antibodyconjugated magnetic nanoparticles through successive fluid wellswhere enhanced mixing patterns substantially reduce the time required for each ELISA stepThis innovative approach enables the implementation of a rapidportablefully automated ELISA test with accuracy comparable to a standard laboratory ELISAIn this SBIR Phase I projectwe will perform the following specific aimsDevelop and optimize a rapid ELISA assay for total vitamin D using the BreviTest portable analyzerandPerform proof of concept testing to detect total vitamin D in simulated blood samples using the BreviTest portable analyzerDeployment of a point ofcare vitamin D test in retail pharmacies and health clinicsparticularly in at risk communitieswill enable easy assessment of vitamin D statuswhich will facilitate targeted dietary supplementation to address vitamin D deficiency in underserved populations PROJECT NARRATIVEThere is a significant health disparity in vitamin D levels across the USwith nonHispanic Blacks having the highest prevalence of vitamin D deficiency followed closely by Mexican AmericansLow vitamin D levels are associated with decreased bone mineral densityincreased fracture riskosteoporosisand a variety of cancersDeficiency is easily treatable with dietary supplementationhoweverthere does not currently exist a point of carecost effective method of measuring a patient s vitamin D statusIn this SBIR Phase I projectBreviTest Technologies proposes to developoptimizeand conduct proof of concept studies for an affordable and quick vitamin D assay that can be used in retail pharmacies and health clinics for easy assessment of vitamin D status