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