Landstuhl

Researchers are evaluating the performance of the SavvyCheck Vaginal Yeast Test, a rapid, point-of-care diagnostic device designed for women to detect Candida antigen in vaginal secretions. The study aims to compare the accuracy of this test when performed by lay users to the standard vaginal Candida yeast culture method (the Reference Method), including analysis by polymerase chain reaction (PCR) and sequencing to understand discrepancies. The study includes both symptomatic and asymptomatic women aged 18 years and older, with a focus on vulvovaginal candidiasis, a common cause of vaginal yeast infections. Participants will use the SavvyCheck Vaginal Yeast Test, which detects Candida antigen through a swab of vaginal secretions. The test is intended for women experiencing symptoms such as increased vaginal discharge, itching, soreness, rash, and burning during urination. The study plans to enroll up to 600 symptomatic women to reach a target of 216 positive Reference Method results, and up to 320 asymptomatic women to reach 170 negative Reference Method results. Testing will be conducted at three military medical centers in the United States and Germany. During the study, women will perform the SavvyCheck test themselves, and results will be compared to the Reference Method culture results. Additional comparisons will include trained user-performed tests, vaginal wet mount microscopy, and PCR sequencing. Researchers will assess sensitivity, specificity, positive and negative predictive values, and concordance between methods. Participants will provide informed consent, and those currently menstruating or recently using vaginal products or medications will be excluded. The study monitors results over 12 months to evaluate test accuracy and reliability.