Replication Data for: PROVE TB 2: Evaluation of Three Molecular Assays Using Tongue Swabs for TB Diagnosis in Symptomatic Adults in South Africa

Background: Molecular assays of tongue swabs may offer promise for non-sputum-based detection of Mycobacterium tuberculosis (Mtb). We evaluated three assays among symptomatic adults presenting for TB diagnosis in South Africa. Methods: We enrolled adults (>=18 years) with presumptive TB presenting to a regional hospital and affiliated outpatient clinics in KwaZulu-Natal, South Africa. Tongue swabs were collected and tested using three molecular assays: GeneXpert Ultra, Quantigen qPCR, and Truenat (Molbio). Two sputum samples were tested using culture and GeneXpert Ultra. Diagnostic performance was compared to a sputum-based microbiological reference standard (positive by either Xpert Ultra or Mtb culture). Subgroup analyses were conducted by HIV status, sputum bacillary load, and history of prior TB disease.