Simple and Inexpensive Diagnostic Tools for Yeast Infections

DESCRIPTION (provided by applicant): Yeast infections (Candida vaginitis) are a very common worldwide ailment in women of reproductive age. The symptoms of CV include vaginal discharge, itching, and burning; although not life threatening they are certainly not trivial to the patient and can impact the quality of life with a burden on the US healthcare system of 1 billion per year. If there was an inexpensive and easy to use diagnostic for yeast infections, then consumers could avoid the unnecessary therapy (and cost) and women who still have the symptoms but do not have Candida vaginitis could then seek a doctor for more appropriate therapy. Clinicians in an outpatient setting will also benefit from having a rapid test for yeast infections that will reduce improper diagnosis and provide more accurate treatment regiment. The long term goal and objective of this phase I project is to develop a rapid and simple consumer diagnostic for yeast infections. Specifically based on a high throughput screen, we have ide ntified 7 potential targets for a yeast diagnostic that will be tested with clinical vaginal swab samples. Once we have refined and chosen the best diagnostic target using biochemical approaches we will convert this bench assay into a home pregnancy-like r apid test format and then retest it with clinical sample to delineate the sensitivity and specificity of the test. The methods employed in this project include 1)protein biochemistry for conjugating the enzyme target to affinity tags 2)clinical microbiolog y of genital tract infections and assay development to test the potential diagnostic targets and correlate the activities with disease, 3) micro-fluidics and lateral flow expertise to convert the bench chemistry into a membrane based system and 4) in phase II mechanical design and engineering to incorporate the components into a stand alone point of care rapid (5 minutes) diagnostic. PUBLIC HEALTH RELEVANCE: Yeast infections are a very common ailment. The benefit to the public health is the commercializatio n of a rapid diagnostic product for yeast infections that will allow women to reliably self-treat or seek a doctor if it is something other than a yeast infection.