Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System
Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System
The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay
 for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS
 (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended
 use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER
 System. ACT Assay performance on the PANTHER System is comparable to performance on the
 TIGRIS System.
This protocol was withdrawn from clinical trials.gov because samples collected under this
 protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia
 trachomatis) Assay. Instead, testing was conducted and results were generated with the
 Gen-Probe APTIMA(R) Combo 2 Assay (for Chlamydia trachomatis and Neisseria gonorrhoeae). See
 Protocol Identification AC2PS-US11-001 (NCT01733069) for results. This action was recommended
 by the RRS team per their email to me on 8 February 2013.
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 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
 IRBapproved 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 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.