Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests

- Estimate the accuracy of the Epistem Genedrive® and MolbioTruenat™ in raw sputum and in
sputum pellets.

- Assess the operational feasibility of Epistem Genedrive® and MolbioTruenat™

- Determine and compare costs between the Epistem Genedrive®, MolbioTruenat™, and Xpert
MTB/RIF tests

Inclusion Criteria:

- • Clinical suspicion of pulmonary TB (including cough ≥2 weeks and at least 1 other
symptom typical of TB);

- Age 18 years or above;

- Willingness to have a study follow-up visit, if necessary, approximately two
months after enrollment

- Willingness to provide 3 sputum specimens at enrollment

- Provision of informed consent.

Exclusion Criteria:

- • Receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment (defined
as combination anti-TB therapy intended to treat active TB) within 60 days prior to
completion of sputum collection;

- Inability to provide informed consent (e.g. mentally impaired)

- Enrolled individuals who do not provide a first sputum sample of ≥ 2ml and a
second and third sputum sample of ≥ 1ml each will be classified as early
exclusions.