Status:

COMPLETED

Evaluation of the QuantiFERON-TB Test.

Lead Sponsor:

QIAGEN Gaithersburg, Inc

Conditions:

Tuberculosis

Eligibility:

All Genders

18-80 years

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.

Eligibility Criteria

Inclusion

  • Low-exposure Risk Group
  • No identified risk factors for TB infection

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2015

Estimated Enrollment :

268 Patients enrolled

Trial Details

Trial ID

NCT02256839

Start Date

October 1 2014

End Date

October 1 2015

Last Update

August 1 2019

Active Locations (1)

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1

Oregon Health & Sciences University

Portland, Oregon, United States, 97239