Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay

Conditions
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Trichomonas Vaginalis

Intervention / Treatment
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* Device: APTIMA Trichomonas vaginalis (ATV) Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be female and attend a participating clinic Subject must be at least 14 years of age at the time of enrollment and is currently sexually active (has had vaginal intercourse within the past 12 months) The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of her parent or legal guardian, unless the site has an institutional review board (IRB)- approved waiver for parental consent for minors) In addition, the subject must meet at least one of the following criteria: Subject must demonstrate symptoms consistent with a suspected STD such as vaginal odor, vaginal discharge, vaginal/vulvar itching or irritation, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort Subject must be asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STD(s) Subject must be asymptomatic and undergoing screening evaluation for possible STDs Subject must be undergoing Pap screening Exclusion Criteria: Subject took antibiotic medications within the last 14 days Subject already participated in the study Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: APTIMA Trichomonas vaginalis (ATV) Assay|APTIMA Trichomonas vaginalis (ATV) Assay|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Percent Agreement Using the TIGRIS Instrument as a Reference. | Positive Percent Agreement Using the TIGRIS Instrument as a Reference. | approximately one year | 
| Negative Percent Agreement Using the TIGRIS Instrument as a Reference. | Negative Percent Agreement Using the TIGRIS Instrument as a Reference. | approximately one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity Rate | Positivity Rate | approximately one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APTIMA Trichomonas vaginalis Assay, APTIMA, trichomonas, trichomonas vaginalis