Prospective Collection of Female and Male Specimens for PANTHER® System Testing

Inclusion Criteria:

- The subject is at least 16 years of age at the time of enrollment and is currently
sexually active (has had 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 his/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:

- The subject reports symptoms consistent with a suspected STI such as abnormal
discharge, genital itching, pain/discomfort during sexual intercourse or urination,
and/or lower abdominal discomfort

- Subject is asymptomatic and known to be partners with, or a contact of, a person with
a confirmed or suspected STI(s)

- Subject is asymptomatic and undergoing screening evaluation for possible STIs

- Subject (female) is asymptomatic and undergoing a routine examination with a pelvic
examination

Exclusion Criteria:

- A potential subject will be ineligible for clinical trial enrollment if the subject,
clinician, or medical record reports any of the following:

- The subject took antibiotic medications within the last 21 days

- Subject already participated in this 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