Status:
TERMINATED
Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
Lead Sponsor:
Siemens Healthcare Diagnostics Inc
Conditions:
Chlamydia
Gonorrhea
Eligibility:
All Genders
18-99 years
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 Neiss...
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 (...
Eligibility Criteria
Inclusion
- 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
- Subject has been on antibiotic therapy within 21 days prior to study enrollment.
- Subject urinated within one hour prior to sample collection.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
2296 Patients enrolled
Trial Details
Trial ID
NCT01167777
Start Date
August 1 2010
End Date
December 1 2010
Last Update
November 26 2015
Active Locations (7)
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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