MONOCLONAL ANTIBODY TEST KIT FOR ROTAVIRUS

ACUTE GASTROENTERITIS IS ONE OF THE MOST COMMON AFFLICTIONS IN HUMANS, WITH HUMAN ROTAVIRUSES AMONG THE MOST IMPORTANT CAUSATIVE AGENTS. THESE PATHOGENS ACCOUNT FOR 40 TO 60 PERCENT OF THE DIAGNOSED CASES OF PEDIATRIC (UNDER AGE 2) GASTROENTERITIS AND ARE THE SINGLE MOST IMPORTANT ETIOLOGIC AGENT FOR ACUTE GASTROENTERITIS IN THE DEVELOPED COUNTRIES. IN THE LESS DEVELOPED COUNTRIES, ROTAVIRUS IS THE THIRD MOSTCOMMONLY DETECTED PATHOGEN. PRESENTLY, DIAGNOSIS IS DEVELOPED FROM RESULTS OF EM IDENTIFICATION (IMPRACTICAL IN MANY SETTINGS), ELISA ASSAYS (IMPRACTICAL FOR SMALL NUMBERS OF SPECIMENS, PRONE TO FALSE POSITIVES), OR EMERGING LATEX ASSAYS. THIS PROPOSAL IS TO DEVELOP MONOCLONAL ANTIBODIES THAT CAN BE EMPLOYED IN A VARIETY OF TEST FORMATS. IN PHASE I, SYNBIOTICS CORPORATION WILL PRODUCE MONOCLONAL ANTIBODIES REACTIVE WITH THE FOUR SEROTYPES PATHOGENIC IN HUMANS. THESE WILL BE TESTED IN EIA ASSAYS FOR SENSITIVITY AND SPECIFICITY AGAINST ATCC CELL LINES, LIKELY CONFOUNDING CELL LINES AND VIRAL OR BACTERIAL STRAINS, AND CHARACTERIZED STOOL SAMPLES. IN PHASE II, THESE ANTIBODIES WILL BE ADAPTED TO LATEX OR SOLID PHASE IMMUNOASSAY KITS TO PROVIDE END PRODUCTS SUITABLE FOR VARIOUS SITUATIONS. RESULTS OBTAINED WITH THESE KITS WILL BE COMPARABLE TO THOSE OBTAINED WITH THE EIA TEST FORMAT. CLINICAL TRAILS WILL THEN BE CONDUCTED.