Trichomonas Vaginalis
Conditions
Keywords
APTIMA Trichomonas vaginalis Assay, APTIMA, trichomonas, trichomonas vaginalis
Brief summary
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.
Interventions
DEVICEAPTIMA Trichomonas vaginalis (ATV) Assay
APTIMA Trichomonas vaginalis (ATV) Assay
Sponsors
Gen-Probe, Incorporated
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Percent Agreement Using the TIGRIS Instrument as a Reference. | approximately one year | Positive Percent Agreement Using the TIGRIS Instrument as a Reference. |
| Negative Percent Agreement Using the TIGRIS Instrument as a Reference. | approximately one year | Negative Percent Agreement Using the TIGRIS Instrument as a Reference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positivity Rate | approximately one year | Positivity Rate |
Countries
United States
Outcome results
None listed