Evaluation of the QuantiFERON-TB Test.

Tuberculosis Clinical Trial

Official title:

Evaluation of the 4th Generation QuantiFERON-TB Gold Test (CST001) for the Detection of Tuberculosis Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256839
• Other study ID #: CST001_USA4
• Status: Completed
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: June 2019
• Source: QIAGEN Gaithersburg, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Device:
• CST_001

Locations

Country	Name	City	State
United States	Oregon Health & Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

QuantiFERON - TB Gold Package Insert (Doc. No. US05990301L). March 2013. Cellestis Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day (At time of enrollment)