Comparative Performance of a Vaginal Yeast Test

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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) 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: To determine the concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy results To determine the concordance between results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing 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: 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) 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: Calculation of concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy Calculation of concordance between results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing 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 four 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. Four, large, regional, DoD military treatment facilities (MTFs) representing two branches of the U.S. military: Womack Army Medical Center (WAMC) at Fort Bragg; Fayetteville, NC Naval Medical Center San Diego (NMCSD); San Diego, CA Naval Medical Center Portsmouth (NMCP); Portsmouth, VA Landstuhl Regional Medical Center (LRMC); Landstuhl, Germany 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.

Official Title
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Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Device: SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic Women Symptomatic women include those women who present with a complaint consistent with symptoms of vaginitis (e.g., increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination). Enrollment will continue at each clinical site until our target number of 216 Reference Method (vaginal Candida yeast culture) positives have been collected. We estimate up to 600 symptomatic women will be enrolled to meet our target. Inclusion Criteria for Symptomatic Women DoD Military Health System beneficiary Have a healthcare appointment at a recruitment clinic 18 years of age or older Must speak and understand English Able to provide informed consent Women experiencing vaginal symptoms, including: increased discharge, itching, soreness and irritation, rash on the labia, and genital burning that may worsen during urination Must determine the test is applicable to her based on her symptoms after she has read the outside device labeling (box label) Asymptomatic Women Asymptomatic women include those women who do not present with a complaint consistent with vaginitis. Enrollment will continue at each clinical site until our target number of 170 Reference Method (vaginal Candida yeast culture) negatives have been collected. We estimate up to 320 asymptomatic women will be enrolled to meet our target. Inclusion Criteria for Asymptomatic Women: DoD Military Health System beneficiary Have a healthcare appointment at a recruitment clinic 18 years of age or older Must speak and understand English Able to provide informed consent Healthy women appearing for routine care without symptoms of vaginal yeast infection Exclusion Criteria: If any of the following criteria are met, a potential subject will be excluded from the study: Currently pregnant Currently menstruating History of sexual violence victimization History of any clinical therapies and/or interventions related to gender confirmation (transgender person) Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days Use of any vaginal product within 24 hours, including contraception (cream, gel, or foam), or douching solutions NOTE: Women who currently have an intrauterine device (IUD) placed are eligible to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic for vaginal yeast<br>Women presenting to the clinic with symptoms of vulvovaginal candidiasis. | Device: SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)<br>* 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.<br>|
| Asymptomatic for vaginal yeast<br>Women presenting to the clinic with no symptoms of vulvovaginal candidiasis. | Device: SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess sensitivity and specificity between lay user-performed SavvyCheck Vaginal Yeast Test result compared to the Reference Method (vaginal Candida yeast culture) | Calculation of sensitivity and specificity of the lay user-performed SavvyCheck Vaginal Yeast Test as compared to the Reference Method (vaginal Candida yeast culture) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Calculation of the positive and negative predictive values of lay user-performed SavvyCheck Vaginal Yeast Test results as compared to the Reference Method (vaginal Candida yeast culture). | 12 months | 
| Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result and the trained user-performed result. | Calculation of concordance between the lay use-performed and the trained user-performed SavvyCheck Vaginal Yeast test results. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal candidiasis, Vaginal yeast culture