Washington Biotechnology (WB), a small business specializing in developing and manufacturing immunoassays, and Program for Appropriate Technology in Health (PATH), propose to optimize and manufacture a low-cost, accurate, simple, one-step test to improve clinical diagnosis of gonorrhea, especially at peripheral and intermediate health-care levels. WB's bank of hybridomas secreting monoclonal antibodies specific for Neisseria gonorrhoeae will be used with an immunochromatographic-strip technology developed at PATH for infectious disease diagnosis. Together, these two organizations have demonstrated feasibility in pilot studies using this technology for detection of N. gonorrhoeae. This proposal covers finalizing the antibody reagents and assay conditions to optimize test performance and demonstrate feasibility using reference strains of gonococci and clinical specimens. Their goal is to produce a simple, inexpensive, one-step test with an accuracy equivalent to or exceeding that of culture. Simple, rapid, yet accurate and cost-effective diagnostics are needed because gonorrhea remains epidemic in parts of the United States and the developing world, and produces significant morbidity. Culture, the diagnostic reference method, is slow, provides only presumptive results without confirmatory testing, and is unavailable in much of the developing world. Syndromic diagnosis and microscopy are not as dependable or accurate as culture.
