AUTOMATED, QUANTITATIVE IMMUNOFLUORESCENT ASSAY

DESCRIPTION (provided by the applicant): Immunofluorescent assays (IFA) are currently used primarily in support of diagnosis of patients with autoimmune disorders and infectious disease. Though it is the method of choice for many rheumatologists, Enzyme-Linked Immuno-sorbent Assays (ELISA) have become a more common immunologic procedure, in part due to cost considerations. Attempts to lower the cost of IFA by automating the readings are problematic due to poor photostability and high non-specific binding of the fluorescent dye. Recently, Hyperion, Inc. has introduced a system for automating preparations of IFA slides and has developed La Jolla BlueTM, a near-infrared-emitting, photostable dye with low nonspecific binding, that allows automation of all steps of the IFA. We have initiated studies with an automated digital instrument to acquire both fluorescence cellular images and quantitative readings of IFA. Experiments with the epifluorescence microscope have demonstrated nuclear fluorescence intensities with a coefficient of variation (CV) of <5 percent. The automated instrument will reduce labor costs for clinical IFA testing and enhance visual binding patterns with quantitative fluorescence intensity measurements. In Phase I, we will investigate feasibility in the key areas for development of the automated instrument. Phase II will proceed with instrument design and validation. PROPOSED COMMERCIAL APPLICATION: Testing with improved diagnostic sensitivity for autoimmune disorders, infectious diseases and various other clinical conditions. About 5,000 of the 25,000 laboratories in industrialized countries test for autoimmune diseases, purchasing pertinent reagent kits annually for $40 million in the US and $100 million worldwide. We expect to place 200, 400 and 600 reading instruments in the first three years, respectively, and to sell to the average user 200 reagent kits ($30,000) for autoimmune testing per year.