The objective is to design and test components of a novel device for the collection and measurement of diagnostic proteins of saliva. The device is composed of a porous outer membrane to remove particles and mucous; inside this envelope there are beads or membrane coated with antibodies to salivary proteins of interest. A calorimetric ELISA is used to quantitate proteins after transfer of solid phase to a simple detector. The model product developed will be for assay of glycated and non-glycated albumin using highly sensitive monoclonal antibodies and an enzyme-linked calorimetric detection protocol easily performed in a medical office. The product will be used in noninvasive monitoring of diabetic control, and is intended for point-of-care and for home-use. The new device will allow development in Phase II of tests for other proteins in saliva, including IgA, IgG, apoB subunit of LDL, and can be expanded to viruses and microorganisms of the upper GI and respiratory tracts. Our commercial goal is to have a range of saliva collection devices to extend analytic and market capabilities beyond the current generation SalivaSac which permits capture and quantitation of small analytes (<12kDa) obtained in an ultrafiltrate of saliva.Phase I is focused on design of a saliva protein collection device and on the development of solid-phase immunoassays for albumins. Phase I will also test a sample prototype and components in normal and diabetic individuals with emphasis on comparison of serum and salivary immunoassayable glycated and nonglycated albumins. Phase II will be concerned with manufacture of a prototype, with enlarging the number of analytes assayed and with commercialization. Target markets (and analytes) have been selected in response to specific market demands and to provide technologically innovative solutions to clinical research goals of the NIH.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
