SBIR-STTR Award

Bacterial vaginosis, or nonspecific vaginitis, and trichomonal vaginitis are two extremely common forms of infectious vaginitis. Both are readily treatable, but recurrences are common. Simple, presumptive screening tests are not commercially available, and diagnosis is often made on the basis of subjective clinical findings. The aim of this research is to determine the technical feasibility of developing a simple, inexpensive, calorimetric test panel that would provide clinicians with reliable, objective, on-site data to assist in diagnosing these disorders. Such a screening panel will permit standardization of various testing procedures and produce uniform test results, thereby allowing comparison of clinical study data. In Phase II, Litmus Concepts, Inc., will develop, optimize, and format the screening panel.

Anticipated Results:
Current tests for infectious vaginitis often rely heavily on subjective clinical findings. A large domestic and international market exists for a quick, simple, reliable, and cost-effective screening tool that can facilitate diagnosis of trichomoniasis and bacterial vaginosis or nonspecific vaginitis. A screening device will be especially useful for on-site clinical use.National Institute of Allergy And Infectious Diseases

Bacterial vaginosis (BV) and trichomoniasis are among the most common sexually transmitted diseases. Both are treatable with metronidazole, but recurrences are frequent. Simple, presumptive screening tests are not available, and diagnoses are often made on the basis of subjective clinical findings. Recent association of BV with placental infection and premature delivery and the association of trichomoniasis with increases in septicemia, premature membrane rupture, and episiotomy infection have increased the need for rapid, accurate, cost-effective, and simple on-site diagnostic tests for these diseases.In Phase I, Litmus Concepts, Inc. (LCI) demonstrated the technical feasibility of developing a simple, inexpensive, colorimetric test panel to provide clinicians with objective, on-site data to assist with the presumptive diagnosis of these disorders. During its Phase II efforts, LCI will conduct the research needed to incorporate its technology into a new metabolic screening panel for presumptive diagnosis of infectious vaginitis. Such a screening panel will permit standardization of various testing procedures and produce uniform test results, thereby allowing comparison of clinical study data.Awardee's statement of the potential commercial applications of the research:Current tests for infectious vaginitis often rely heavily on subjective clinical findings. A large domestic and international market exists for a quick, simple, reliable, and cost-effective screening tool that can facilitate diagnosis of trichomoniasis and BV. A screening device will be especially useful for on-site clinical use.National Institute of Allergy and Infectious Diseases (NIAID)