Evaluation of the QuantiFERON-TB Test.

Evaluation of the 4th Generation QuantiFERON-TB Gold 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 specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.

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