"Solana™ Trichomonas Assay Field Study"

March 16, 2018 updated by: Quidel Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7030
        • University of North Carolina, Div. of Infectious Diseases
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington in Seattle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Female subjects symptomatic for Trichomonas vaginalis infection.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic
Subjects will be categorized by the clinician as symptomatic for Trichomonas vaginalis infection.
Device: Solana Trichomonas Assay Testing
Specimen collection of urine and/or vaginal swabs for testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trichomonas Test Result
Time Frame: 2 days
Testing results will be received by testing site for current FDA cleared tests
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quidel Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2015

Primary Completion (ACTUAL)

August 15, 2016

Study Completion (ACTUAL)

August 15, 2016

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (ESTIMATE)

October 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV-01-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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