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

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ClinicalTrials.gov Identifier: NCT01733069
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : April 24, 2013
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Chlamydia Trachomatis Neisseria Gonorrhoeae Infection Device: APTIMA COMBO 2 Assay (AC2 Assay)

Detailed Description:

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The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).

Study Design
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Study Type : Observational
Actual Enrollment : 1912 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System
Study Start Date : November 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012
Groups and Cohorts
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Group/Cohort Intervention/treatment
No treatment Device: APTIMA COMBO 2 Assay (AC2 Assay)
APTIMA COMBO 2 Assay (AC2 Assay


Outcome Measures
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Primary Outcome Measures :
  1. APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type [ Time Frame: Baseline ]
    Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)


Biospecimen Retention:   Samples With DNA
4 specimens will be collected from each female subject in the following order: 1 first-catch urine specimen, 1 vaginal swab specimen (patient or clinician-collected), 1 cervical specimen (using a broomlike collection device or a brush/spatula combination), and 1 endocervical swab specimen. An additional cervical specimen may be collected from female subjects for other clinical trial purposes or research studies. Up to 2 specimens will be collected from each male subject in the following order: 1 urethral swab specimen and 1 first-catch urine specimen

Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Male and Females at least 14 years of age at the time of informed consent and sexually active.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733069


Locations
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United States, Indiana
Wishard Health Services Department of Pathology Wishard Health Services
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana State University Health Center
New Orleans, Louisiana, United States, 70122
United States, Massachusetts
New England Center for Clinical Research
Fall River, Massachusetts, United States, 02720
United States, North Carolina
University of North Carolina Chapel Hill STD Clinic
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Planned Parenthood Northeast Ohio
Akron, Ohio, United States, 44302
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
Cincinnati, Ohio, United States, 45229
United States, Texas
Planned Parenthood Houston and Southeast Texas
Houston, Texas, United States, 77023
Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
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Study Director: Jennifer Reid, PhD Gen-Probe, Incorporated
More Information
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Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01733069    
Other Study ID Numbers: AC2PS-US11-001
ACTPS-US10-001 ( Other Identifier: Gen-Probe )
First Posted: November 26, 2012    Key Record Dates
Results First Posted: April 24, 2013
Last Update Posted: January 14, 2014
Last Verified: November 2013
Additional relevant MeSH terms:
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Gonorrhea
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
 Sexually Transmitted Diseases
Infection
Neisseriaceae Infections