Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
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ClinicalTrials.gov Identifier: NCT01167777 |
Recruitment Status :
Terminated
(Siemens Management decided not to release the product in the USA.)
First Posted : July 22, 2010
Last Update Posted : November 26, 2015
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Condition or disease |
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Chlamydia Gonorrhea |
The study was terminated
This clinical trial protocol outlines the analytical and clinical performance characteristics that will be evaluated to demonstrate equivalency of the VERSANT CT/GC DNA 1.0 (kPCR) Assay for product registration. The Gen-Probe APTIMA Combo 2 Assay will be used as the CE-marked comparative method. The studies conducted during the clinical trial are intended to provide data to support the safety and effectiveness, as well as the labeling claims for the VERSANT CT/GC Assay. The study objectives are as follows:
- To demonstrate concordance with the Gen-Probe APTIMA Combo 2 Assay;
- To estimate the positive and negative predictive values for each specimen type included in the study;
- To estimate the indeterminate rate for each specimen type included in the study;
- To estimate the equivocal rate for each specimen type; and
- To assess reproducibility of the VERSANT CT/CG DNA 1.0 Assay (kPCR) using the VERSANT kPCR Molecular System.
Two (2) studies will be conducted to validate the analytical and clinical performance characteristics of the CT/GC DNA 1.0 (kPCR) Assay. Table 1 provides an overview of these studies.
Study Type : | Observational |
Actual Enrollment : | 2296 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Group/Cohort |
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male/female
Symtomatic and asymptomatic males and females attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC.
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- Prevalence of CT and/or GC disease by clinical site [ Time Frame: Study terminated ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subject is 18 years of age or older.
- Subject signed an IRB approved informed consent form.
- Subject is able to follow verbal and written instructions.
Exclusion Criteria:
- Subject has been on antibiotic therapy within 21 days prior to study enrollment.
- Subject urinated within one hour prior to sample collection.

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): NCT01167777
United States, Alabama | |
University of Alabama At Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Los Angeles County Department of Public Health | |
Los Angeles, California, United States, 90007 | |
San Francisco Dept of Public Health | |
San Francisco, California, United States, 94103 | |
San Joaquin County Public Health Services | |
Stockton, California, United States, 95205 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 | |
United States, Minnesota | |
Hennepin County Medical Center | |
Minneapolis, Minnesota, United States, 55415 |
Study Director: | NORMAND DESPRES, PhD | Siemens Healthcare Diagnostics |
Responsible Party: | Siemens Healthcare Diagnostics Inc |
ClinicalTrials.gov Identifier: | NCT01167777 |
Other Study ID Numbers: |
MCSA-VkPCRCTGC-200810-PRO |
First Posted: | July 22, 2010 Key Record Dates |
Last Update Posted: | November 26, 2015 |
Last Verified: | November 2015 |
CT GC NG chlamydia gonorrhoeae |
Chlamydia Infections Gonorrhea Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Infection Neisseriaceae Infections |