Xpert MTB/XDR Clinical Evaluation Trial

Multicentre Clinical Trial to Assess the Performance of the Xpert MTB/XDR Assay for INH- and Second-line Resistance Detection

FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the development, evaluation and introduction of an Xpert MTB/XDR assay

Inclusion Criteria:

• • Age 18 years or above;

  • Symptoms suggesting pulmonary TB, i.e. persistent cough (generally ≥3 weeks or as per local definition of TB suspect), and at least one of the following:

    • Previously received >1 month of treatment for a prior TB episode or
    • Failing TB treatment with positive sputum smear or culture after ≥3 months of a standard TB treatment or
    • Had close contact with a known drug-resistant TB case or
    • Newly diagnosed with MDR-TB within the last 30 days or
    • Previously diagnosed with MDR-TB and failed TB treatment with positive sputum smear or culture after ≥3 months of a standard MDR-TB treatment regimen

Patients meeting the above criteria will be screened by Xpert MTB/RIF or Xpert MTB/RIF Ultra. TB patients meeting the following criteria will be included in the study:

• A clear Mtb-positive and RIF-resistant or RIF-sensitive result by Xpert MTB/RIF or Xpert MTB/RIF Ultra
• Provision of informed consent;
• Production of an adequate quantity (>3mL) of sputum

Exclusion Criteria:

• Participants will be excluded from the study if informed consent is not provided.