Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae

Stopped early

Conditions studied: Chlamydia, Gonorrhea

In brief

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).

Key facts

Study ID

NCT01167777

Run by

Siemens Healthcare Diagnostics Inc

People needed

2296

Starts

2010-08-01

Expected to finish

2010-12-01

Last updated by the study team

2015-11-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subject has been on antibiotic therapy within 21 days prior to study enrollment.
• Subject urinated within one hour prior to sample collection.

Where it is running

• University of Alabama At Birmingham — Birmingham, Alabama, United States
• Los Angeles County Department of Public Health — Los Angeles, California, United States
• San Francisco Dept of Public Health — San Francisco, California, United States
• San Joaquin County Public Health Services — Stockton, California, United States
• Indiana University — Indianapolis, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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