Chlamydia Infections, Gonorrhea, Trichomonas Infections
Conditions
Brief summary
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.
Interventions
DEVICEAPTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
In Vitro Diagnostic Assays
Sponsors
Gen-Probe, Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed