"Solana™ Trichomonas Assay Field Study"
"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.
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.
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.