"Solana™ Trichomonas Assay Field Study"

Quidel

Status: Completed

Conditions: Trichomonas Vaginalis

Treatments: Device: Solana Trichomonas Assay Testing

Study type: Observational

Funder types: Industry

Identifiers

NCT02566447

TV-01-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

750 participants in 1 patient group

Symptomatic

Description:

Subjects will be categorized by the clinician as symptomatic for Trichomonas vaginalis infection.

Treatment:

Device: Solana Trichomonas Assay Testing