Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
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ClinicalTrials.gov Identifier: NCT02795975
Recruitment Status :
(Sponsor business decision)
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Layout table for eligibility information
Ages Eligible for Study:
14 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Sexually active women ≥14 years of age with or without symptoms of STIs will be eligible for enrollment. Participating clinical collection sites may include US family planning, public health, and STI clinics.
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.
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.