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

Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests for the Diagnosis of Pulmonary Tuberculosis in Comparison to Geneexpert MTB/RIF

Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem Genedrive® and MolbioTruenat™ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF assay using a gold standard of four cultures

• 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.