Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 2,296
- Locations
- 7
- Primary Endpoint
- Prevalence of CT and/or GC disease by clinical site
Study Overview
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:
- 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Prevalence of CT and/or GC disease by clinical site
Time Frame: Study terminated
Secondary Outcomes
No secondary outcomes reported