Diagnostic performance of oral swabs for non-sputum based TB diagnosis in a TB/HIV endemic setting

De-identified participant level data of a diagnostic performance study evaluating oral swab analysis (OSA) for tuberculosis (TB) diagnosis in Kenya between November 2016 and March 2017. In this cross-sectional study, buccal swabs and sputum from 100 participants with suspected TB in outpatient clinics in Kenya were collected from enrollment (visit 1) and subsequent morning visits (visit 2). Buccal swabs were collected at both visits, two buccal swabs (left and right buccal surface) and a control swab (exposed to air only); and then analyzed for IS6110-targeted (M. tuberculosis-specific) qPCR analysis. A predetermined threshold quantitation cycle (Cq) <38 was considered positive (lower Cq indicating higher copies and stronger/more positive signal indicating higher mycobacterial burden). Sputum was collected at both visits for AFB smear, Xpert MTB/RIF (Xpert), and culture (MGIT, Manual Mycobacterial Growth System). Dataset includes results of this evaluation as well as basic demographic information, HIV status, and tuberculosis symptom screening.