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

NCT ID: NCT02687529

Last Updated: 2019-06-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-27

Study Completion Date

2016-05-26

Brief Summary

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To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.

Detailed Description

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Conditions

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Tuberculosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Low Risk

Tested with CST001

CST001

Intervention Type DEVICE

Known Risk

Tested with CST001

CST001

Intervention Type DEVICE

Interventions

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CST001

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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QIAGEN Gaithersburg, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VA Palo Alto Health Care System (VAPAHCS)

Palo Alto, California, United States

Site Status

Countries

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United States

References

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QuantiFERON-TB Gold Package Insert (DOC. No. US05990301L). March 2013. QIAGEN Inc.

Reference Type BACKGROUND

Shams 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.

Reference Type BACKGROUND
PMID: 15265931 (View on PubMed)

Lewinsohn 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.

Reference Type BACKGROUND
PMID: 17892322 (View on PubMed)

Other Identifiers

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CST001_USA7

Identifier Type: -

Identifier Source: org_study_id

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