Trials / Completed
CompletedNCT02566447
"Solana™ Trichomonas Assay Field Study"
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 750 (actual)
- Sponsor
- Quidel Corporation · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Solana Trichomonas Assay Testing | Specimen collection of urine and/or vaginal swabs for testing |
Timeline
- Start date
- 2015-10-15
- Primary completion
- 2016-08-15
- Completion
- 2016-08-15
- First posted
- 2015-10-02
- Last updated
- 2018-03-20
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02566447. Inclusion in this directory is not an endorsement.