Comparative Performance of a Vaginal Yeast Test

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.

Primary Objective:

The primary objective is to establish lay user performance criteria (sensitivity and specificity) of the SavvyCheck Vaginal Yeast Test in comparison to the Reference Method (vaginal Candida yeast culture)

Secondary Objectives:

1. To determine the positive predictive value and negative predictive value of the lay user-performed SavvyCheck Vaginal Yeast Test in comparison to the Reference Method (vaginal Candida yeast culture) 2. To determine the concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. trained user-performed SavvyCheck Vaginal Yeast Test

Exploratory Objectives:

1. To determine the concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy results 2. To determine the concordance between results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing 3. To determine the concordance between results determined by the Reference Method (vaginal Candida yeast culture) -vs. PCR and sequencing

Primary Endpoints:

Calculation of sensitivity and specificity of the lay user-performed SavvyCheck Vaginal Yeast Test as compared to the Reference Method (vaginal Candida yeast culture)

Secondary Endpoints:

1. Calculation of positive and negative predictive value of lay user-performed SavvyCheck Vaginal Yeast Test results as compared to the Reference Method (vaginal Candida yeast culture) 2. Calculation of concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test results -vs. trained user-performed SavvyCheck Vaginal Yeast Test results

Exploratory Endpoints:

1. Calculation of concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy 2. Calculation of concordance between results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing 3. Calculation of concordance between results determined by the Reference Method (vaginal Candida yeast culture) -vs. PCR and sequencing

Women, aged 18 years and older, symptomatic and asymptomatic for vaginitis will be enrolled in the study. We estimate that it will require a total enrollment of up to 600 symptomatic women at all clinical sites combined, to achieve the target of at least n=216 Reference Method (vaginal Candida yeast culture) positives. In addition, a combined total of 320 asymptomatic women will be enrolled in the study from the four clinical sites combined, to achieve the target of at least n=170 Reference Method (vaginal Candida yeast culture) negatives.

Three, large, regional, DoD military treatment facilities (MTFs)

1. Womack Army Medical Center (WAMC) at Fort Liberty; Fayetteville, NC 2. Landstuhl Regional Medical Center (LRMC); Landstuhl, Germany 3. Brooke Army Medical Center (BAMC); Fort Sam Houston, TX

The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for the detection of Candida antigen in vaginal secretions sampled by a swab, as an aid for identification of vulvovaginal candidiasis 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 over-the-counter use.

• Assess positive and negative predictive values of the lay-user SavvyCheck Vaginal Yeast Test result as compared to the Reference Method (vaginal Candida yeast culture) [Срок оценки: 12 months]
• Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result and the trained user-performed result. [Срок оценки: 12 months]