Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
1 other identifier
observational
66
1 country
1
Brief Summary
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2015
CompletedFirst Submitted
Initial submission to the registry
February 16, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2016
CompletedResults Posted
Study results publicly available
June 6, 2019
CompletedJune 19, 2019
June 1, 2019
11 days
February 16, 2016
September 18, 2018
June 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites
To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site.
1 day (At time of enrollment)
Study Arms (2)
Low Risk
Tested with CST001
Known Risk
Tested with CST001
Interventions
Eligibility Criteria
Patients who have either a low risk or known risk for TB exposure.
You may qualify if:
- 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.
You may not qualify if:
- Currently taking therapy for active tuberculosis or latent TB infection for more than 14 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto Health Care System (VAPAHCS)
Palo Alto, California, 94304, United States
Related Publications (3)
QuantiFERON-TB Gold Package Insert (DOC. No. US05990301L). March 2013. QIAGEN Inc.
BACKGROUNDShams H, Klucar P, Weis SE, Lalvani A, Moonan PK, Safi H, Wizel B, Ewer K, Nepom GT, Lewinsohn DM, Andersen P, Barnes PF. Characterization of a Mycobacterium tuberculosis peptide that is recognized by human CD4+ and CD8+ T cells in the context of multiple HLA alleles. J Immunol. 2004 Aug 1;173(3):1966-77. doi: 10.4049/jimmunol.173.3.1966.
PMID: 15265931BACKGROUNDLewinsohn DA, Winata E, Swarbrick GM, Tanner KE, Cook MS, Null MD, Cansler ME, Sette A, Sidney J, Lewinsohn DM. Immunodominant tuberculosis CD8 antigens preferentially restricted by HLA-B. PLoS Pathog. 2007 Sep 21;3(9):1240-9. doi: 10.1371/journal.ppat.0030127.
PMID: 17892322BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Study Coordinator
- Organization
- QIAGEN Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2016
First Posted
February 22, 2016
Study Start
October 27, 2015
Primary Completion
November 7, 2015
Study Completion
May 26, 2016
Last Updated
June 19, 2019
Results First Posted
June 6, 2019
Record last verified: 2019-06