2008 Multiplexed Opsonophagocytic Assay (OPA) for Streptococcus pneumoniae Southeast
Award: Excellence in Technology Transfer
Syphilis is a sexually transmitted disease (STD) caused by the spirochete bacterium Treponema pallidum. Over 100,000 cases of adult syphilis are reported worldwide each year. In addition, syphilis can be transmitted congenitally and it affects more than 3,000 infants annually. A technology invented by the Centers for Disease Control and Prevention (CDC) is directed toward the development of a rapid, point-of-care test for the improved detection of syphilis. This invention detects nontreponemal antibodies, helping to fill a long-felt need for a combined test detecting both treponemal and nontreponemal antibodies. One of the major technical challenges overcome by this technology is the ability to attach cardiolipin, the nontreponemal antigen, to membrane surfaces. The nonpolar nature of the fatty acid side chains of the cardiolipin antigen imparts a high degree of hydrophobicity to the molecule and makes it difficult to bind to polar surfaces. The present technology provides an approach for modifying cardiolipin so that it can be covalently conjugated to a protein carrier that can be used as a linker to attach to a solid surface without losing its antigenicity. When combined with the treponemal antigen, this improved method for binding cardiolipin to a solid support enables a rapid test to detect treponemal and nontreponemal antigens in the same assay. This allows rapid testing for syphilis, which is critical so that patients are notified of their infection status immediately, begin treatment promptly, and avoid unknowingly infecting additional sexual partners. The value of this dual antigen detection assay for the diagnosis of syphilis was readily recognized by the private sector. The CDC’s Technology Transfer Office entered into seven commercial evaluation license agreements (CELAs) with three international and four domestic diagnostic reagent manufacturers. This technology has also led to the implementation of two Cooperative Research and Development Agreements (CRADAs) and a nonexclusive patent license agreement. Thus, in addition to its benefits to public health, the technology also gives economic benefits to the private sector by providing a successful commercial product and providing additional jobs and resources directed at this problem.