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Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection

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ClinicalTrials.gov Identifier: NCT02687529
Recruitment Status : Completed
First Posted : February 22, 2016
Results First Posted : June 6, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
QIAGEN Gaithersburg, Inc

Study Description
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Brief Summary:
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.

Condition or disease Intervention/treatment
Tuberculosis Device: CST001

Study Design
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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
Actual Study Start Date : October 27, 2015
Actual Primary Completion Date : November 7, 2015
Actual Study Completion Date : May 26, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Low Risk
Tested with CST001
 Device: CST001
Known Risk
Tested with CST001
 Device: CST001


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites [ Time Frame: 1 day (At time of enrollment) ]
    To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have either a low risk or known risk for TB exposure.
Criteria

Low Risk and Known Risk Cohorts

Inclusion Criteria:

  • Compensated and uncompensated members (current or future) of the Department of Veterans Affairs with no identified symptoms of active TB disease
  • Age greater than 18 years or less than 80 years.

Exclusion Criteria:

  • Currently taking therapy for active tuberculosis or latent TB infection for more than 14 days.
Contacts and Locations
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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): NCT02687529


Locations
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United States, California
VA Palo Alto Health Care System (VAPAHCS)
Palo Alto, California, United States, 94304
Sponsors and Collaborators
QIAGEN Gaithersburg, Inc
More Information
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Publications:
QuantiFERON-TB Gold Package Insert (DOC. No. US05990301L). March 2013. QIAGEN Inc.

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Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT02687529    
Other Study ID Numbers: CST001_USA7
First Posted: February 22, 2016    Key Record Dates
Results First Posted: June 6, 2019
Last Update Posted: June 19, 2019
Last Verified: June 2019
Keywords provided by QIAGEN Gaithersburg, Inc:
Tuberculosis
TB
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Infections
Mycobacterium Infections
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Latent Infection