Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples

Hologic

Status: Terminated

Conditions: Gonorrhea; Chlamydia Trachomatis

Study type: Observational

Funder types: Industry

Identifiers

NCT02795975

A10417-AC2PS-CSP-02

Details and patient eligibility

About

The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.

Enrollment: 1,766 patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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.