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

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.

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.