Comparative Performance of a Vaginal Yeast Test
ConditionVulvovaginal Candidiasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniformed Services University of the Health Sciences
About this trial
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 criteria
Qualifiers
DoD Military Health System beneficiary
Have a healthcare appointment at a recruitment clinic
18 years of age or older
Must speak and understand English
Disqualifiers
Currently menstruating
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
Trial design
Treatments tested in this trial
- SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Uniformed Services University of the Health Sciences
Lead sponsor
Savvyon Diagnostics Ltd.
Collaborator
Source ClinicalTrials.gov