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Evaluation of the QuantiFERON-TB Test.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02256839
Recruitment Status : Completed
First Posted : October 6, 2014
Results First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
QIAGEN Gaithersburg, Inc

Brief Summary:
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

Condition or disease Intervention/treatment
Tuberculosis Device: CST_001

Detailed Description:
To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.

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Study Type : Observational
Actual Enrollment : 268 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the 4th Generation QuantiFERON-TB Gold Test (CST001) for the Detection of Tuberculosis Infection
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
non TB infection
Group tested with CST_001
Device: CST_001
low exposure risk
Group tested with CST_001
Device: CST_001



Primary Outcome Measures :
  1. Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives [ Time Frame: 1 day (At time of enrollment) ]
    To compare the clinical specificity of the CST001 assay to the QuantiFERON-TB Gold test in low TB exposure risk subjects and non TB infected subjects based on an assessment of known risk factors. These subjects had no identified risk factors of TB infection.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have either low-exposure rist to tuberculosis or have non-tuberculous mycobacterial infections
Criteria

Low-exposure Risk Group

Inclusion Criteria:

  • No identified risk factors for TB infection

Exclusion Criteria:

  • Age less than 18 years or greater than 80 years
  • Identified Risk Factors For TB Infection

Non-tuberculous mycobacterial infection Group

Inclusion Criteria:

  • history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria

Exclusion Criteria:

  • Age less than 18 years or greater than 80 years
  • Identified Risk Factors For TB Infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256839


Locations
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United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
QIAGEN Gaithersburg, Inc
Investigators
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Principal Investigator: Kevin Winthrop, MD, M.P.H Oregon Health and Science University
Publications:
QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.

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Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT02256839    
Other Study ID Numbers: CST001_USA4
First Posted: October 6, 2014    Key Record Dates
Results First Posted: August 1, 2019
Last Update Posted: August 1, 2019
Last Verified: June 2019
Keywords provided by QIAGEN Gaithersburg, Inc:
Tuberculosis
TB
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections