Abstract:Rationale: TBDx automated microscopy is a novel technology that processes digital microscope images to identify acid-fast bacilli (AFB). TBDx as part of a diagnostic algorithm could improve the diagnosis of tuberculosis (TB), but its performance characteristics have not been formally tested.Objective: To evaluate the performance of the TBDx automated microscopy system in algorithms for diagnosis of TB. Methods: Prospective samples from patients with presumed TB were processed in parallel with conventional smear microscopy, TBDx microscopy, and liquid culture. AllTBDx positive specimens were also tested with Xpert MTB/RIF (GXP). We evaluated the sensitivity and specificity of two algorithms: 1) TBDX-GXP (TBDx, with positive specimens tested by Xpert MTB/RIF) and 2) TBDx alone, against the gold standard liquid-media culture. as having 1-9 putative AFB (low positive). An algorithm in which "low positive" results on TBDx were confirmed by GXP had 78% sensitivity (85/109) and 99.8% specificity (889/900), requiring 21% (207/1009) specimens to be processed by GXP. As a standalone test, a "high positive" result on TBDx had 62% sensitivity and 99.7% specificity.Conclusions: TBDx used in diagnostic algorithms with GXP provided reasonable sensitivity and high specificity for active TB while dramatically reducing the number GXP tests performed. As a stand-alone microscopy system, performance was equivalent to a highly experienced TB microscopist.