RecruitingNCT05079711

Comparative Performance of a Vaginal Yeast Test

Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture

Sponsor

Uniformed Services University of the Health Sciences

Enrollment

1,200 participants

Start Date

Mar 18, 2022

Study Type

OBSERVATIONAL

Conditions

Vulvovaginal candidiasis

Summary

The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test) for people with vulvovaginal candidiasis. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)

The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for detection of Candida antigen in vaginal secretions, sampled by a swab as an aid for identification of vulvovaginal candidiasis (VVC), as a primary cause of vaginal yeast infections. The SavvyCheck Vaginal Yeast Test is designed for use by women experiencing vaginal symptoms, including: increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination. The SavvyCheck Vaginal Yeast Test is indicated for OTC use.