APTIMA Trichomonas vaginalis (ATV) Assay
DeviceAPTIMA Trichomonas vaginalis (ATV) Assay
NCT Number: NCT01427023
The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay.
These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
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Notify Me14 year and older
Female
Observational
University of Alabama, Birmingham, Birmingham, Alabama, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
APTIMA Trichomonas vaginalis (ATV) Assay
Time frame: approximately one year
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
Time frame: approximately one year
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
Time frame: approximately one year
Positivity Rate
Gen-Probe, Incorporated
Industry
Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay
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