Evaluation of the QuantiFERON-TB Test.

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

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