This proposal requests funding for the development of a nucleic acid-based C.trachomatis dipstick test of urine specimens specifically designed with regard to format and production procedures suitable for resource-poor settings. The first goal is to achieve sensitivity equivalent to or better than culture and a specificity of greater than 99%. The second goal is to produce the test in the U.S. at a production cost (labor plus material cost) of less than 50 cents. The final goal is to make these tests available to developing countries at cost which is affordable locally. This will necessitate the transfer of manufacturing technology to private or semi-private institutions in developing countries for production and distribution. The technology transfer agreement will require a relatively modest technology transfer fee and designate a public-sector price ceiling which would permit a fixed but low profit margin. After completing the initial goal of developing a chlamydia urine dipstick, the basic technology will subsequently be extended to other sexually transmitted diseases such as syphilis and chancroid, as well as to other infectious diseases, such as hepatitis and human immunodeficiency virus (HIV) infection to provide tests that are urgently needed by transfusion centers and hospitals in the developing world.
