"Solana™ Trichomonas Assay Field Study"

Completed

Conditions studied: Trichomonas Vaginalis

In brief

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.

Key facts

Study ID

NCT02566447

Run by

Quidel Corporation

People needed

750

Starts

2015-10-15

Expected to finish

2016-08-15

Last updated by the study team

2018-03-20

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• University of North Carolina, Div. of Infectious Diseases — Chapel Hill, North Carolina, United States
• University of Washington in Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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