Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
2 other identifiers
observational
1,912
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2010
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
November 26, 2012
CompletedResults Posted
Study results publicly available
April 24, 2013
CompletedJanuary 14, 2014
November 1, 2013
1.3 years
November 20, 2012
March 7, 2013
November 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
No treatment
Interventions
Eligibility Criteria
Male and Females at least 14 years of age at the time of informed consent and sexually active.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Wishard Health Services Department of Pathology Wishard Health Services
Indianapolis, Indiana, 46202, United States
Louisiana State University Health Center
New Orleans, Louisiana, 70122, United States
New England Center for Clinical Research
Fall River, Massachusetts, 02720, United States
University of North Carolina Chapel Hill STD Clinic
Chapel Hill, North Carolina, 27599, United States
Planned Parenthood Northeast Ohio
Akron, Ohio, 44302, United States
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
Cincinnati, Ohio, 45229, United States
Planned Parenthood Houston and Southeast Texas
Houston, Texas, 77023, United States
Biospecimen
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Reid, Director of Clinical Affairs
- Organization
- Gen-Probe Incorporated
Study Officials
- STUDY DIRECTOR
Jennifer Reid, PhD
Gen-Probe, Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2012
First Posted
November 26, 2012
Study Start
November 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
January 14, 2014
Results First Posted
April 24, 2013
Record last verified: 2013-11