Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Siemens Healthcare Diagnostics Inc
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.
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be if
Subject has been on antibiotic therapy within 21 days prior to study enrollment.
Subject urinated within one hour prior to sample collection.
