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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01167777

Enrollment

2296

Registered

2010-07-22

Start date

2010-08-31

Completion date

2010-12-31

Last updated

2015-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia, Gonorrhea

Keywords

CT, GC, NG, chlamydia, gonorrhoeae

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Prevalence of CT and/or GC disease by clinical site	Study terminated

Countries

United States

Outcome results