Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01733069 |
Recruitment Status :
Completed
First Posted : November 26, 2012
Results First Posted : April 24, 2013
Last Update Posted : January 14, 2014
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Condition or disease | Intervention/treatment |
---|---|
Chlamydia Trachomatis Neisseria Gonorrhoeae Infection | Device: APTIMA COMBO 2 Assay (AC2 Assay) |
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The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).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 |
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 |
Group/Cohort | Intervention/treatment |
---|---|
No treatment |
Device: APTIMA COMBO 2 Assay (AC2 Assay)
APTIMA COMBO 2 Assay (AC2 Assay |
- 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

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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 |
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.

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
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 |
Study Director: | Jennifer Reid, PhD | Gen-Probe, Incorporated |
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 |
Gonorrhea Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial |
Sexually Transmitted Diseases Infection Neisseriaceae Infections |