Comparative Performance of a Vaginal Yeast Test

Conditions

• Vulvovaginal Candidiasis

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test) — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Mar 18, 2022

Status verified

May 2024

Primary completion

Aug 30, 2026

Completion

Aug 30, 2026

Study Design

Enrollment

1,200 participants (estimated)

Arms

• Arm: Symptomatic for vaginal yeast
  Women presenting to the clinic with symptoms of vulvovaginal candidiasis.
• Arm: Asymptomatic for vaginal yeast
  Women presenting to the clinic with no symptoms of vulvovaginal candidiasis.

Primary Outcome Measure

Assess sensitivity and specificity between lay user-performed SavvyCheck Vaginal Yeast Test result compared to the Reference Method (vaginal Candida yeast culture) [ Time Frame: 12 months ]

Central Contacts

• Elizabeth A Kostas-Polston, PhD
  301.295.1531
  [email protected]
• Mary B Engler, PhD
  301.295.3427
  [email protected]

Locations (2)

Find similar trials in Fort Bragg, NC

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