SBIR-STTR Award

The objective of this proposal is to use mouse monoclonal antibodies to HTLV-III to evaluate the feasibility of detecting HTLV antigen expression on T lymphocytes in clinical specimens from patients with lyphadenopathy syndrome and overt AIDS, and in individuals in high risk groups. This will be done by: (1) producing an array of mouse monoclonals to HTLV-III antigens by immunizing with selected antigens in extensive immunization protocols; (2) selecting hybrid cultures reactive to HTLV-III by ELISA screening and Western Blotting and to clone and characterize hybrids which express selective reactivity patterns to HTLV-111; (3) to evaluate selected monoclonal antibodies for use in detecting HTLVIII antigen expression on human T lymphocytes by flow cytometry; and (4) to use selected monoclonal antibodies in a retrospective trial to compare (a) ELISA reactivity, (b) Western Blotting, (c) T lymphocyte H/S ratio, and (d) HTLV antigen expression by flow cytometry on a bank of selected samples.National Heart, Lung, and Blood Institute (NHLBI)

Epitope, Inc. has developed a series of monoclonal antibodies to the gene-products of the HIV, the etiological agent of AIDS. This array of antibodies react with distinct gag, env, and pol-derived proteins. At least two of these monoclonal reagents detect HIV antigens of the surface of a circulatory lymphocyte subpopulation (T4 cells) from AIDS, ARC, and asymptomatic seropositive patients, but not seronegative individuals. Using flow cytometry, a direct test for the AIDS virus has been developed and evaluated in a blinded clinical trial. We now propose(1) to evaluate additional monoclonal antibodies for detection of HIV proteins on cells an in body fluids,(2) to conduct an extensive clinical trial to compare the flow cytometry test with a slide test, and(3) to conduct a longitudinal study to follow seroconversion of high risk clients.National Heart, Lung and Blood Institute (NHLBI)