SBIR-STTR Award

Navix, Inc. proposes to develop a rapid, one-step immuno-chromatographic assay for identification of malaria and dengue-infested mosquitoes. This assay will be based on the existing know-how at Navix by which sensitive test-strip based panel assays provide results in less than 15 minutes and are stable at ambient storage conditions. The present proposal aims at preparing and evaluating a panel assay developed from dengue- and malaria-specific polyclonal/monoclonal antibodies. Phase I will involve (1) Selection of the most appropriate antibodies for incorporation into the malaria and dengue assay that meet the required criteria; (2) Development of a prototype dengue assay with the required sensitivity; (3) Development of a malaria assay with the required sensitivity; and (4) Production of about 1000 assays of each kind for laboratory/field evaluation. Successful completion of these tasks can result in the development of panel assays that could indicate precise causative agents during a single use. Timely identification of arthropod-borne disease threat will benefit both the Department of Defense (DOD) and the various civilian health agencies throughout the world. Since the present technology furnishes an assay system that can be stored ambiently, it can be transported and used without any loss in performance for over 12 months. The proposed assay system is simple to use and interpret, and developed to be effective in adverse environments.

IMMUNOASSAY DETECTION ARTHROPOD-BORNE PATHOGENS DISEASE THREAT MONITORING MALARIA. The overall goal of Phase II of this project is to develop a rapid, one step, rugged immuno-chromatographic dip-stick assay for the identification of malaria-infected mosquitoes. This assay is based on the existing know-how at Navix by which sensitive test-strip based single analyte or panel assays provide results in less than 15 minutes and the tests are stable at ambient storage conditions. The results of Phase I have demonstrated that the antibody reagents provided by the contracting agency against various malarial sporozoite antigens can be used effectively to generate highly sensitive and robust assays economically. Phase II will involve: (1) Production and testing of a consistent product. Tests will be produced in quantities where significant data can be generated and evaluated. As the project matures, at various time lines, updated formats will be provided to ensure improvement in performance or results. (2) The tests will be compared to the available "gold-standard" assays. (3) Development of panel assays, where single assays capable of detecting several different species/polymorphs of human malaria sporozoites will be developed. (4) Development of panel assays for other targets such as for the detection of Dengue virus types 1 to 4, flaviviruses, alphaviruses and phleboviruses.

Benefits:
Economic and timely identification of arthropod-borne disease threat will benefit both the Department of Defense (DoD) and the various civilian health agencies throughout the world. Since the present technology furnishes an assay system that can be stared ambiently, it can be transported and used without any loss in performance for over 12 months. The proposed assay system is simple to use and interpret, and developed to be effective in adverse environment.