The long-term goal of this project is to develop an effective and rapid diagnostic test for bacterial vaginosis which infects about 35% of women. This test is based on the fact that consistently elevated levels of sialidase enzyme was observed in the vaginal samples of women who had bacterial vaginosis.
The specific aims for this period include: (1) analytical studies on synthetic chromogenic substrates using pure stock-culture aerobic and anaerobic isolates, (2) pre-clinical trials on synthetic chromogenic substrate compounds using patient vaginal fluid samples, (3) scale-up synthesis of the most promising compound, (4) develop a packaging format for the product, (5) conduct a planned human clinical trial, and (6) file 510(k) application with the US FDA. Based on the results of previous studies, effective treatment of bacterial vaginosis in pregnant women reduces preterm labor and preterm delivery by 50%. The new test developed from this technology will significantly aid physicians in correctly and rapidly diagnosing bacterial vaginosis, which is believed to be under diagnosed due to limitations of available methods.
This new diagnostic test will aid physicians to correctly and rapidly diagnose the common disease, bacterial vaginosis. Published data has shown that effective treatment of diagnosed cases of bacterial vaginosis reduces the incidence of preterm birth by 50%.
