Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System

Completed

Conditions studied: Chlamydia Trachomatis, Neisseria Gonorrhoeae Infection

In brief

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.

Key facts

Study ID

NCT01733069

Run by

Gen-Probe, Incorporated

People needed

1912

Starts

2010-11-01

Expected to finish

2012-02-01

Last updated by the study team

2014-01-14

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Wishard Health Services Department of Pathology Wishard Health Services — Indianapolis, Indiana, United States
• Louisiana State University Health Center — New Orleans, Louisiana, United States
• New England Center for Clinical Research — Fall River, Massachusetts, United States
• University of North Carolina Chapel Hill STD Clinic — Chapel Hill, North Carolina, United States
• Planned Parenthood Northeast Ohio — Akron, Ohio, United States
• Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology — Cincinnati, Ohio, United States
• Planned Parenthood Houston and Southeast Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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