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.
Study Type
OBSERVATIONAL
Enrollment
750
Specimen collection of urine and/or vaginal swabs for testing
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
Trichomonas Test Result
Testing results will be received by testing site for current FDA cleared tests
Time frame: 2 days
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