Prospective Assessment of TBDx Feasibility
Prospective Assessment of TBDx Feasibility
The purpose of this study will be to determine the performance characteristics of TBDx with
 culture as a gold standard. In addition, the investigators will assess the laboratory
 technicians' appraisal and technical suitability of the TBDx system.
This will be a blinded, prospective study to determine the performance of the TBDx system for
 detection of pulmonary TB in comparison to LED microscopy and culture as a gold standard. The
 study will involve recruitment of 300 TB suspects per site with a high workload and
 experienced technicians. Participants will be recruited under the FIND TB Reference Materials
 project and leftover sputum samples used for the assessment of the TBDx.
Inclusion Criteria:

 -  Persistent cough (>2 weeks) and at least one other typical symptom of pulmonary TB
 (fever, night sweats, malaise, recent weight loss, contact with active case,
 hemoptysis, chest pain, loss of appetite)

 -  Provision of informed consent (FIND TB Reference Materials)

 -  Provision of sputum for adequate testing

 Exclusion Criteria:

 -  Patients receiving any anti-TB medication, in the 60 days prior to testing.

 -  Patients with only extra-pulmonary disease