SIMPLE VISUAL TESTS FOR DIAGNOSIS OF AUTOIMMUNE DISEASE

CURRENT SEROLOGIC TESTS AIMED AT PROVIDING DIAGNOSTIC AND PROGNOSTIC INFORMATION ON PATIENTS WITH SUSPECTED AUTOIMMUNE DISEASES ARE BASED ON DATED TECHNOLOGY. THE TWO TECHNOLGIES MOST COMMONLY EMPLOYED, INDIRECT IMMUNOFLUORESCENCE AND DOUBLE DIFFUSION, ARE RELATIVELY COMPLICATED AND TIME-CONSUMING PROCEDURES, UTILIZE EXPENSIVEREAGENTS, AND REQUIRE THE USE OF SOPHISTICATED EQUIPMENT AND HIGHLY TRAINED TECHNOLOGISTS. THE GOAL IS TO DEVELOP SIMPLER, LESS EXPENSIVE SEROLOGICAL TESTS THAT CAN BE COMPETENTLY USED IN SMALLER, DECENTRALIZEDLABORATORIES FOR AIDING IN DIAGNOSIS OF VARIOUS AUTOIMMUNE DISEASES. THE BASIC TECHNOLOGY EXPLORED WILL BE AN ENZYME-LINKED IMMUNOSORBENT ASSAY UTILIZING VARIOUS TYPES OF PROTEIN- AND NUCLEIC-ACID-BINDING MEMBRANES AS A SOLID-PHASE SUPPORT. CLINICALLY RELEVANT AUTOANTIGENS, EITHER FROM CRUDE TISSUE EXTRACTS, OR IMMUNOCHEMICALLY PURIFIED OR WELL-DEFINED CLONED ANTIGENS, WILL BE LINKED TO SUITABLE SOLID-PHASE MEMBRANE SUPPORTS. FOR CERTAIN DISEASES, SEVERAL ANTIGENS WILL BE APPLIED IN DISCRETE SPOTS OR ZONES ON THE MEMBRANE SO THAT AN "AUTOANTIBODY PROFILE" OF A GIVEN PATIENT CAN BE DETERMINED IN ONE SIMPLE PROCEDURE. THE FINAL FORMAT OF THESE MEMBRANE-BASED DIAGNOSTIC DEVICES COULD BE OF THE DIPSTICK TYPE, OR EVEN A FULLY INTEGRATED CAPILLARY OR SUCTION-DRIVEN SYSTEM. IN EITHER CASE, THE POSITIVE RESULT WILL BE A VISUALLY DISCERNIBLE COLOR CHANGE ON THE MEMBRANE. THE TOTAL TEST TIME COULD BE UNDER 5 MINUTES.