Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
The objectives of this study are to establish the performance characteristics of the AC2
 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the
 TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and
 reproducibility of the AC2 Assay on the PANTHER System.
The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from
 protocol ACTPS-US10-001(NCT01358799).

 The registration for NCT01358799 was withdrawn because the samples were not tested under
 protocol ACTPS-US10-001, instead they were tested under the protocol registered here
 AC2PS-US11-001 (NCT01733069).
Inclusion Criteria:

 •The subject is at least 14 years of age at the time of informed consent and is sexually
 active

 -  The subject reports symptoms consistent with a suspected STD (sexually transmitted
 disease) such as abnormal discharge, genital itching, pain/discomfort during sexual
 intercourse or urination, and/or lower abdominal discomfort.

 -  If the subject is asymptomatic, the subject is known to be partners with, or a contact
 of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation
 for a possible STD(s), and/or is scheduled for a routine exam that may include a
 pelvic exam

 -  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 IRB
 (institutional review board) approved waiver for parental consent for minors)

 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

 -  The subject is underage (as defined by the IRB (institutional review board) or state
 law), without the documented consent of her/his parent or legal guardian (exception:
 sites that have an IRBapproved waiver for parental consent for minors)

 -  The subject is determined by the investigator to be medically unsuitable for
 participation in this study (eg, medical history of concurrent illness that could
 result in an unacceptable risk to the subject) Concurrent participation in other
 clinical study(ies) may be acceptable, with approval by the investigator and sponsor.