Chlamydia Trachomatis, Gonorrhea
Conditions
Brief summary
The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.
Interventions
None listed
Sponsors
Hologic, Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The subject is ≥14 years of age at the time of enrollment and is currently sexually active (eg, has had penile/vaginal intercourse within the past 6 months). * For subjects under 18 years old, assent of the subject and/or parental/legal guardian permission has been obtained if required by the institutional review board (IRB). * The subject and/or legally authorized representative is willing and able to undergo the informed consent process prior to study participation, and: * reports symptoms consistent with a suspected STI (eg, abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort); or * is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI; or * is asymptomatic and undergoing screening evaluation for possible STIs; or * is asymptomatic and undergoing a routine pelvic examination.
Exclusion criteria
* The subject took antibiotic medications within the last 21 days prior to collection. * The subject already participated in the study. * The subject has a history of illness that the PI or designee considers could interfere with or affect the conduct, results, and/or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity | Enrollment ongoing until estimated March 2017 |
Countries
United States
Outcome results
None listed