Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in Pulmonary Tuberculosis Suspects

Inclusion Criteria: * Suspected pulmonary TB (more information on the criterion can be found in the protocol) * Men and women age equal to or greater than 18 years * Ability and willingness of candidate or legal guardian/representative to provide informed consent * Collection of two sputum samples for AFB smear and culture collected within 7 days prior to entry. * Availability of two samples for Xpert MTB/RIF testing collected within 7 days prior to entry. * Determination and/or documentation of HIV status * For HIV-positive candidates, a CD4+ cell count obtained within 45 days prior to study entry or drawn at the time of entry at any laboratory that has a CLIA certification or its equivalent. Exclusion Criteria: * Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing * Receipt of more than 7 cumulative days of antibiotics intended for bacterial treatment that may have anti-tuberculosis activity, within the 14 days prior to first sputum collection * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements