Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
Study Details
Study Description
Brief Summary
Multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kPCR technology. The assay is intended for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC).
Detailed Description
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:
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To demonstrate concordance with the Gen-Probe APTIMA Combo 2 Assay;
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To estimate the positive and negative predictive values for each specimen type included in the study;
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To estimate the indeterminate rate for each specimen type included in the study;
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To estimate the equivocal rate for each specimen type; and
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Prevalence of CT and/or GC disease by clinical site [Study terminated]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is 18 years of age or older.
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Subject signed an IRB approved informed consent form.
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Subject is able to follow verbal and written instructions.
Exclusion Criteria:
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Subject has been on antibiotic therapy within 21 days prior to study enrollment.
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Subject urinated within one hour prior to sample collection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama At Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Los Angeles County Department of Public Health | Los Angeles | California | United States | 90007 |
| 3 | San Francisco Dept of Public Health | San Francisco | California | United States | 94103 |
| 4 | San Joaquin County Public Health Services | Stockton | California | United States | 95205 |
| 5 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 6 | Johns Hopkins University | Baltimore | Maryland | United States | 21205 |
| 7 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
Sponsors and Collaborators
- Siemens Healthcare Diagnostics Inc
Investigators
- Study Director: NORMAND DESPRES, PhD, Siemens Healthcare Diagnostics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCSA-VkPCRCTGC-200810-PRO