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OpenTrials
Completed

NCT Number: NCT02566447

"Solana™ Trichomonas Assay Field Study"

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.

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Key information

Conditions

Trichomonas Vaginalis

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • The study is limited to females. Male subjects are not accepted.
  • At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Treatment and study plan

Solana Trichomonas Assay Testing

Device

Specimen collection of urine and/or vaginal swabs for testing

Primary outcomes

  1. Trichomonas Test Result

    Time frame: 2 days

    Testing results will be received by testing site for current FDA cleared tests

Sponsors and collaborators

Lead sponsor

Quidel Corporation

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2015
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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