Trichomonas Vaginalis
Conditions
Brief summary
The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument.
Detailed description
This study is to establish the clinical performance of the Solana® Trichomonas Assay for the detection of Trichomonas vaginalis in vaginal swabs and urine samples as compared to a combined reference method of direct wet mount microscopy and a FDA-cleared device.
Interventions
DEVICESolana Trichomonas Assay Testing
Specimen collection of urine and/or vaginal swabs for testing
Sponsors
Quidel Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Female subjects will be recruited from the general population as they present to the clinical facility. Subjects will be categorized by the clinician as either asymptomatic or symptomatic for Trichomonas vaginalis infection. Symptoms in women can include: * Greenish-yellow, frothy vaginal discharge with a strong odor * Painful urination * Vaginal itching and irritation * Discomfort during intercourse * Lower abdominal pain (rare)
Exclusion criteria
1. The study is limited to females. Male subjects are not accepted. 2. At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trichomonas Test Result | 2 days | Testing results will be received by testing site for current FDA cleared tests |
Countries
United States
Outcome results
None listed