Comparative Performance of a Vaginal Yeast Test

Description

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.

Conditions

Vulvovaginal Candidiasis

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Study Overview

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Study Details

Study overview

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.

Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture

Comparative Performance of a Vaginal Yeast Test

Condition
Vulvovaginal Candidiasis
Intervention / Treatment

-

Contacts and Locations

Fort Bragg

Womack Army Medical Center, Fort Bragg, North Carolina, United States, 28310

Fort Sam Houston

Brooke Army Medical Center, Fort Sam Houston, Texas, United States, 78234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. DoD Military Health System beneficiary
  • 2. Have a healthcare appointment at a recruitment clinic
  • 3. 18 years of age or older
  • 4. Must speak and understand English
  • 5. Able to provide informed consent
  • 6. Women experiencing vaginal symptoms, including: increased discharge, itching, soreness and irritation, rash on the labia, and genital burning that may worsen during urination
  • 7. Must determine the test is applicable to her based on her symptoms after she has read the outside device labeling (box label)
  • 1. DoD Military Health System beneficiary
  • 2. Have a healthcare appointment at a recruitment clinic
  • 3. 18 years of age or older
  • 4. Must speak and understand English
  • 5. Able to provide informed consent
  • 6. Healthy women appearing for routine care without symptoms of vaginal yeast infection
  • 1. Currently menstruating
  • 2. History of any clinical therapies and/or interventions related to gender confirmation (transgender person)
  • 3. Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days
  • 4. Use of any vaginal product within 24 hours, including contraception (cream, gel, or foam), or douching solutions

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Uniformed Services University of the Health Sciences,

Elizabeth A Kostas-Polston, PhD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences

Study Record Dates

2026-08-30