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Comparative Performance of a Vaginal Yeast Test

NCT05079711 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

  • Vulvovaginal Candidiasis

Interventions

DEVICE

SavvyCheck 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.

Sponsors & Collaborators

  • Savvyon Diagnostics Ltd.

    collaborator UNKNOWN

  • Uniformed Services University of the Health Sciences

    lead FED

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2026-08-30
Completion
2026-08-30

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05079711 on ClinicalTrials.gov