Multi-center Evaluation of the VERSANT® CT/GC DNA 1.0 Assay (kPCR)in Detecting C. Trachomatis and N. Gonorrhoeae
NCT ID: NCT01167777
Last Updated: 2015-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2296 participants
OBSERVATIONAL
2010-08-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject signed an IRB approved informed consent form.
* Subject is able to follow verbal and written instructions.
Exclusion Criteria
* Subject urinated within one hour prior to sample collection.
18 Years
99 Years
ALL
No
Sponsors
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Siemens Healthcare Diagnostics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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NORMAND DESPRES, PhD
Role: STUDY_DIRECTOR
Siemens Healthcare Diagnostics
Locations
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University of Alabama At Birmingham
Birmingham, Alabama, United States
Los Angeles County Department of Public Health
Los Angeles, California, United States
San Francisco Dept of Public Health
San Francisco, California, United States
San Joaquin County Public Health Services
Stockton, California, United States
Indiana University
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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MCSA-VkPCRCTGC-200810-PRO
Identifier Type: -
Identifier Source: org_study_id