Development of an Assay to Rapidly Determine Folate Insufficiency in the Field

Folic acid is a water-soluble vitamin that serves as a cofactor in 1-carbon transfers required for DNA replication. Humans lack the enzymes to synthesize folate, so dietary intake is necessary. Its deficiency is associated with neural tube defects (NTDs) in fetuses. The global burden of folate insufficiency as it relates to NTDs is estimated to be over 200,000 pregnancies yearly. Many NTDs can be prevented if a woman consumes folic acid daily before and during early pregnancy. Although mandatory folic acid fortification has increased blood folate concentrations in the U.S .. folate insufficiency remains a severe problem on a global scale. The lack of data on blood folate levels hampers public health efforts to identify, intervene, and evaluate populations at risk for NTDs. This gap in data is primarily due to the inability to perform large-scale national surveillance studies of folate levels and NTDs in countries with remote and isolated populations. To this end, Lynntech proposes to develop a field-based assay that will allow for the measurement of red blood cell (RBC) folate levels. Our technology utilizes Lynntech's sample preparation module to first capture RBCs, followed by RBC hemolysis to release the folate for visual detection by lateral flow assay (LFA). Relevance of this research to public health: Folate insufficiency is directly linked to neural tube defects which are birth defects of the brain and spinal cord. The ability to collect data of folate level in a population in non-laboratory settings will allow the government to implement proper policy to increase the folate intake and reduce the health issues associated with folate deficiency.