TEST KIT DEVELOPMENT FOR AGENTS OF BIOLOGICAL ORIGIN

NEW HORIZONS DIAGNOSTICS (NHD) HAS SEVERAL PATENTS FOR NOVEL RAPID AND SIMPLE LIGAND-RECEPTOR ASSAYS. NHD'S GOAL HAS BEEN TO PRODUCE ASSAYS SIMPLE ENOUGH TO BE PERFORMED BY UNSKILLED OR UNTRAINED INDIVIDUALS WITHOUT ANY EQUIPMENT NEEDS. THROUGH THE COMMERCIAL INTRODUCTION OF THE DIRECT GROUP A STREP SMART (SENSITIVE MEMBRANE ANTIGEN RAPID TEST), NHD HAS PROVEN ITSELF TO BE IN THE FOREFRONT OF RAPID IMMUNO-DIAGNOSTIC TECHNOLOGY. THE GROUP A STREP SMART CAN DETECT AS FEW AS 2000 STREPTOCOCOCCI FROM A SWAB IN LESS THAN 7 MINUTES. IN CLINICAL EVALUATION, THE SMART HAS PROVEN TO BE MORE SIMPLE AND SIGNIFICANTLY MORE SENSITIVE THAN LATEX AGGLUTINATION, ELISA-MEMBRANE, OR LIPOSOME-MEMBRANE BASED GROUP A STREP ASSAYS. THE SMART PROCEDURE USES A SWAB FOR SAMPLE COLLECTION, WHICH IS REACTED WITH A METAL SOL LABELED ANTIBODY AND THEN PLACED IN A SMART DEVICE WHEREIN ANY IMMUNOCOMPLEXES FORMED ARE CAPTURED ON A MEMBRANE, APPEARING AS A PINK TO PURPLE SPOT. THE SMART KIT IS STORED AND PERFORMED AT ROOM TEMPERATURES AND THEREFORE IS CAPABLE OF BEING USED AS A FIELD DETECTION/IDENTIFICATION KIT. IN THE PHASE I PROGRAM, A PROTOTYPE RAPID AND SIMPLE ASSAY IN THE SMART FORMAT WILL BE DEVELOPED FOR 2 PATHOGENS OR TOXINS OF INTEREST TO THE CONTRACTOR. THE SPECIFIC ANTIBODIES AND ANTIGEN WOULD BE PROVIDED BY THE CONTRACTOR. WE WILL ALSO EXAMINE THE FEASIBILITY OF TESTING TWO AGENTS FROM A SINGLE SWAB SIMULTANEOUSLY WITHIN A SINGLE SMART DEVICE.