Status:

COMPLETED

Evaluation of the QuantiFERON-TB Test.

Lead Sponsor:

QIAGEN Gaithersburg, Inc

Conditions:

Tuberculosis

Eligibility:

All Genders

18-70 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 sensitivity of the CST001 assay to the QuantiFERON-TB Gold assay in patients with bacteriologically confirmed and untreated TB disease.

Eligibility Criteria

Inclusion

  • Clinical symptoms consistent with a high probability of having TB disease
  • Receiving, or are likely to receive, therapy for active TB
  • Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing.
  • Between 18 and 70 years of age.

Exclusion

  • Taken therapy for active TB or latent TB for more than 14 days
  • Culture confirmation of M. tuberculosis not obtained

Key Trial Info

Start Date :

February 2 2015

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 26 2016

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT02253537

Start Date

February 2 2015

End Date

April 26 2016

Last Update

June 18 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Washington

Seattle, Washington, United States, 98195