Diagnostic Accuracy of the MiniDock MTB Assay Using Tongue Swab Specimens for Detection of Pulmonary Tuberculosis, A Systematic Review

Diagnostic test accuracy systematic review and meta-analysis evaluating the performance of the MiniDock MTB assay on tongue swab specimens for detection of pulmonary tuberculosis in individuals with presumptive TB. The review will assess sensitivity and specificity against pre-specified microbiological reference standards, with primary analysis using culture-only reference standards and secondary analyses using composite microbiological reference standards and Xpert MTB/RIF Ultra as an exploratory comparator. Subgroup analyses will examine bacillary burden or smear status, HIV status, setting, sputum availability, age, reference standard, and swab collection method where data permit. Risk of bias will be assessed using QUADAS-2, and diagnostic accuracy will be synthesized using a bivariate random-effects model and HSROC approach.