Evaluation of the QuantiFERON-TB Test.

Completed

• Conditions: Tuberculosis
• Interventions: Device: CST_001

• Registration Number: NCT02256839
• Lead Sponsor: QIAGEN Gaithersburg, Inc

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2014-09-29
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-06
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2018-09-18
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-05
• Last Update Submitted: 2019-06-05
• Results First Posted: 2019-08-01
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non TB infection	CST_001	Group tested with CST_001
low exposure risk	CST_001	Group tested with CST_001

Primary Outcome Measures

Name	Time	Method
Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives	1 day (At time of enrollment)	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.

Trial Locations

Locations (1)

Oregon Health & Sciences University; 🇺🇸 Portland, Oregon, United States