Study Comparing the SavvyCheck Vaginal Yeast Test to Standard Culture for Detecting Vulvovaginal Candidiasis in Women

What this Trial Is About

This research aims to establish performance standards for the SavvyCheck Vaginal Yeast Test when used by lay users compared to the standard vaginal yeast culture method for detecting Candida. The study focuses on both symptomatic and asymptomatic women, using additional methods like PCR and fungal sequencing to understand discrepancies between test results. It evaluates sensitivity, specificity, predictive values, and agreement between different test performers and methods. Participants will use the SavvyCheck Vaginal Yeast Test, a rapid, over-the-counter device that detects Candida antigen from vaginal swabs. The study enrolls women with and without symptoms of vulvovaginal candidiasis, targeting specific numbers to achieve positive and negative reference culture results. This observational study is conducted at multiple military treatment facilities, involving both lay users and trained users performing the test for comparison. During the study, participants will have evaluations including the SavvyCheck test performed by themselves and trained users, vaginal yeast cultures, wet mount microscopy, and PCR with sequencing when needed. Researchers will assess test accuracy, agreement of results, and predictive values over 12 months. Women must provide informed consent and meet language and symptom-related criteria. The study includes follow-up through clinical appointments and data collection from up to 920 women total.

Comparative Performance of a Vaginal Yeast Test