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TerminatedNCT01167777Updated Nov 26, 2015

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

An observational study in Chlamydia and Gonorrhea, sponsored by Siemens Healthcare Diagnostics Inc. Terminated at 7 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-11-26.

Sponsored by Siemens Healthcare Diagnostics Inc · Observational

Why this study was terminated
Siemens Management decided not to release the product in the USA.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,296
Ages
18 Years to 99 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Chlamydia
  • Gonorrhea

Keywords

  • CT
  • GC
  • NG
  • chlamydia
  • gonorrhoeae
03

In context

Chlamydia Infections

121 studies on the registry are indexed under Chlamydia Infections; 21 are open to participants now.

This study's enrollment of 2,296 is above the median of 399 across 29 observational studies indexed under Chlamydia Infections.

Browse Chlamydia Infections studies →

Lead sponsor

Siemens Healthcare Diagnostics Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Symptomatic and asymptomatic male and female patients attending STD, family planning, public health and women's health clinics, or other applicable centers, who are being screened for CT or GC

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

Exclusion Criteria:

  • Subject has been on antibiotic therapy within 21 days prior to study enrollment.
  • Subject urinated within one hour prior to sample collection.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,296 participants (actual)

Groups and cohorts

  • male/female

    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.

06

What researchers measure

Primary outcomes

  1. Prevalence of CT and/or GC disease by clinical site

    Time frame: Study terminated

07

Study locations

7 sites
  • University of Alabama At Birmingham
    Birmingham, Alabama 35294, United States
  • Los Angeles County Department of Public Health
    Los Angeles, California 90007, United States
  • San Francisco Dept of Public Health
    San Francisco, California 94103, United States
  • San Joaquin County Public Health Services
    Stockton, California 95205, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • Hennepin County Medical Center
    Minneapolis, Minnesota 55415, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01167777
Lead sponsor
Siemens Healthcare Diagnostics Inc
Responsible party
Sponsor
First posted
Jul 22, 2010
Start date
Aug 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Nov 26, 2015

Study contacts

NORMAND DESPRES, PhD
study director · Siemens Healthcare Diagnostics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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