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

Study Overview
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Brief Summary
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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.

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 The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).

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

Conditions
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Chlamydia Trachomatis, Neisseria Gonorrhoeae Infection

Intervention / Treatment
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* Device: APTIMA COMBO 2 Assay (AC2 Assay)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br> | Device: APTIMA COMBO 2 Assay (AC2 Assay)<br>* APTIMA COMBO 2 Assay (AC2 Assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type | Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity) | Baseline |