"Solana™ Trichomonas Assay Field Study"

Completed

• Conditions: Trichomonas Vaginalis
• Interventions: Device: Solana Trichomonas Assay Testing

• Registration Number: NCT02566447
• Lead Sponsor: Quidel Corporation

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.

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Study Start: 2015-10-15
• Primary Completion: 2016-08-15
• Study Completion: 2016-08-15
• Status Verified: 2017-08
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 750

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic	Solana Trichomonas Assay Testing	Subjects will be categorized by the clinician as symptomatic for Trichomonas vaginalis infection.

Primary Outcome Measures

Name	Time	Method
Trichomonas Test Result	2 days	Testing results will be received by testing site for current FDA cleared tests

Trial Locations

Locations (4)

University of North Carolina, Div. of Infectious Diseases; 🇺🇸 Chapel Hill, North Carolina, United States

University of Washington in Seattle; 🇺🇸 Seattle, Washington, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States