Evaluation of the QuantiFERON-TB Test.

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

268 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

Brief Summary

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

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Detailed Description

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

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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non TB infection

Group tested with CST\_001

CST_001

Intervention Type DEVICE

low exposure risk

Group tested with CST\_001

CST_001

Intervention Type DEVICE

Interventions

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CST_001

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* No identified risk factors for TB infection

* 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

Non-tuberculous mycobacterial infection Group

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes