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

Siemens

Status: Terminated

Conditions: Gonorrhea; Chlamydia

Study type: Observational

Funder types: Industry

Identifiers

NCT01167777

MCSA-VkPCRCTGC-200810-PRO

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,296 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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.

Trial design

2,296 participants in 1 patient group

male/female

Description:

Symtomatic and asymptomatic males and females attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC.