Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays

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, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.

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

Conditions
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Chlamydia Infections, Gonorrhea, Trichomonas Infections

Intervention / Treatment
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* Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/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 his/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: The subject reports symptoms consistent with a suspected sexually transmissible infection (STI) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s) Subject is asymptomatic and undergoing screening evaluation for possible STIs Subject is asymptomatic and undergoing a routine examination with a pelvic examination Exclusion Criteria: The subject took antibiotic medications within the last 21 days Subject already participated in this 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: 16 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment<br> | Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays<br>* In Vitro Diagnostic Assays<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease |  | approximately one year |