GeneXpert MTB/RIF assay in the diagnosis of urinary tuberculosis from urine specimens.

Conventional bacteriological methods are not generally helpful in diagnosing urinary tuberculosis (UTB). GeneXpert is endorsed for the detection of pulmonary tuberculosis, whereas the data on its utility for urine specimens is limited. In this study, we aimed to evaluate its performance on urine specimens in a country with high TB incidence. A total of 163 suspected UTB patients were consecutively enrolled in the analysis, including 37 (22.7%) culture-positive and 44 (27.0%) clinically diagnosed UTB cases. Compared with conventional culture, the sensitivity of GeneXpert (94.6%) was significantly higher than that of smear microscopy (40.5%, P < 0.001). When setting clinical diagnosis as gold standard, 51 out of 81 clinically diagnosed UTB cases were detected by GeneXpert, demonstrating a sensitivity of 63.0%, which was significantly higher than that of smear microscopy (18.5%, P < 0.001) and culture (45.7%, P = 0.027), respectively. In addition, the proportion of UTB cases in the migrant population was significantly higher than that in the resident population (P = 0.019). To conclude, our data demonstrate that GeneXpert outperforms AFB smear and culture for the detection of MTB in urine samples, which provides an alternative for the diagnosis of UTB. The migrant population and previously diagnosed TB cases are high risk factors for developing UTB cases.