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.

Study Overview

• Status: Completed
• Conditions: Chlamydia Trachomatis; Neisseria Gonorrhoeae Infection
• Intervention / Treatment: 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The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).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 Type: Observational
• Enrollment (Actual): 1912

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Wishard Health Services Department of Pathology Wishard Health Services
  • Louisiana
    • New Orleans, Louisiana, United States, 70122
      • Louisiana State University Health Center
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Chapel Hill STD Clinic
  • Ohio
    • Akron, Ohio, United States, 44302
      • Planned Parenthood Northeast Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
  • Texas
    • Houston, Texas, United States, 77023
      • Planned Parenthood Houston and Southeast Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and Females at least 14 years of age at the time of informed consent and sexually active.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No treatment	Device: APTIMA COMBO 2 Assay (AC2 Assay); APTIMA COMBO 2 Assay (AC2 Assay

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gen-Probe, Incorporated

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (ESTIMATE): November 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 14, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Gonorrhea
• Other Study ID Numbers: AC2PS-US11-001; ACTPS-US10-001 (Gen-Probe)