Evaluation of the QuantiFERON-TB Test.
Evaluation of the QuantiFERON-TB Test.
To compare the results of the investigational test to the currently approved QuantiFERON-TB
 Gold In-Tube test.
To compare the sensitivity of the CST001 assay to the QuantiFERON-TB Gold assay in patients
 with bacteriologically confirmed and untreated TB disease.
Inclusion Criteria:

 -  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 Criteria:

 -  Taken therapy for active TB or latent TB for more than 14 days

 -  Culture confirmation of M. tuberculosis not obtained