Evaluation of the QuantiFERON-TB Test.

QIAGEN Gaithersburg, Inc268 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

268

Conditions

Tuberculosis

Interventions

CST_001DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Sciences University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives

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.

Time frame: 1 day (At time of enrollment)

Data from ClinicalTrials.gov

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