The objective of the proposed research is the development of a low cost, rapid, simple test to detect infection with Human T-cell Lymphotropic Virus Types I and II. These viruses are associated with a fatal condition called Adult T-cell Leukemia and a debilitating disorder termed Tropical Spastic Paraparesis. The proposed test will utilize and modify the Company's INSTI immunodiagnostic format which has already provided the basis of a 30 second HIV-1/HIV-2 test. Significant technological innovations proposed include the ability to use whole blood and visual differentiation between IgG, IgM and IgA classes of antibodies. The INSTI-HTLV test is expected to take less than 1 minute and 2 steDs to perform compared to the several hours and 10 steps required by currently available ELISA and agglutination products. The test will address a major market need for field tests in high incidence and developing countries. It will also provide a major advance for the routine screening of pregnant mothers and other point of care testing in industrialized countries.Awardee's statement of the potential commercial applications of the research:The Commercial applications include routine testing of pregnant women, routine testing in STD clinics, emergency room testing, diagnosis and small volume blood screening in the U.S., Europe and Japan.National Center for Infectious Diseases (NCID)
