Bio-Star proposes to develop a solid phase assay for the simultaneous detection of three or more analytes (antigens and/or antibodies), using an optical interference signal. This optical immunoassay (OIA) is a technique for the direct physical detection of the immunochemical reaction and generally does not require the use of any added reagents. The signal can be detected with the unaided eye, or with a reflectometer or ellipsometer for quantification. Each assay will be conducted on a distinct reaction zone on the slide. We propose to convert three ELISA tests into the OIA format during phase I. These tests detect the presence of antibodies associated with autoimmune diseases. We will demonstrate the ability to immobilize three distinct classes of molecules on our substrate, and to generate a detectable signal with OIA. In phase II we will build the final tri-analyte prototype, then use this assay development experience to design a tri-analyte test for three diseases of military significance. The final test will be sensitive, rapid, and suitable for use in both laboratory and field environments. The flexibility and simplicity of the oia format makes this technology ideally suited to the development of tri-analyte immunoassays.
