EARLY IMMUNE RESPONSE-DETECTION BY RAPID NEOPTERIN ASSAY

THE LONG-TERM OBJECTIVE OF THIS RESEARCH IS DEVELOPMENT, OPTIMIZATION AND COMMERCIAL SALE OF AN INNOVATIVE, RAPID ANDCOST-EFFECTIVE SCREENING METHOD FOR NEOPTERIN AND ITS HYDROGENATED CONGENERS IN BODY FLUIDS. ULTIMATELY, IN PHASEII THIS WILL TAKE THE FORM OF A VISIBLE CUT-OFF EIA SCREEN PERFORMED DIRECTLY ON A BLOOD SPOT OBTAINED BY FINGER OR EAR-STICK. NEOPTERIN LEVELS ARE A SENSITIVE INDICATOR OF T-LYMPHOCYTE ACTIVITY AND HAVE SIGNIFICANCE AS A SCREENING TEST OF BLOOD DONORS FOR INFECTIOUS DISEASES AND AS AN EARLYSIGN OF TRANSPLANT REJECTION. IMMEDIATE OBJECTIVES OF THE PHASE I FEASIBILITY STUDY ARE: DEVELOPMENT OF POLYCLONAL ANTIBODIES TO NEOPTERIN AND ITS HYDROGENATED FORMS (DIHYDRO- AND TETRAHYDRONEOPTERIN); DEVELOPMENT AND OPTIMIZATION OF AN I-125 RIA FOR TOTAL NEOPTERIN DETERMINATION IN SERUM, ASSESSING FEASIBILITY FOR ITS CONVERSION TO NEOPTERIN DETERMINATION IN A 1/8" FILTER PAPER BLOOD-SPOT AND TO NEOPTERIN EIA (PHASE II DEVELOPMENT); AND PRELIMINARY CONVERSION TO A PROTOTYPE RIA FOR TOTAL NEOPTERIN IN CAPILLARY BLOOD ON FILTER PAPER. THIS HIGHLY INNOVATIVE NEW SCREENING TEST HAS TREMENDOUS POTENTIAL FOR COMMERCIAL AND CLINICAL APPLICATIONS WHICH INCLUDE: AIDS SCREENING--TO COMPLEMENT AND PRE-DATE HIV POSITIVITY, BLOOD DONOR SCREENING--TO EXCLUDE ACUTE INFECTIOUS DISEASE OR CATASTROPHIC CHRONIC ILLNESS WHEN NO SYMPTOMS ARE APPARENT; AND TRANSPLANT REJECTION--TO DETECT REJECTION EPISODES PRIOR TO CLINICAL SYMPTOMS.