Lead Sponsor

Hologic, Inc.

Age

14 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

•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.

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