Xpert MTB/RIF Ultra improved the diagnosis of paucibacillary tuberculosis: A prospective cohort study

Objectives We assessed the diagnostic performance of Xpert MTB/RIF Ultra (Xpert Ultra) in comparison to Xpert MTB/RIF (Xpert) for the detection of paucibacillary tuberculosis (TB). Methods Smear-negative sputum, pleural fluid and cerebrospinal fluid (CSF) were collected from TB suspects at Beijing Chest Hospital (Beijing, China) and were examined using smear, Xpert and culture. Xpert Ultra was tested using specimens stored at −80 °C. Drug susceptibility testing (DST) was conducted for all of the isolates recovered. The performances of Xpert Ultra and Xpert were evaluated using composite reference standard (CRS) as gold standard, which included clinical, laboratory, histopathological, radiological and follow-up features. Results Totally 689 cases were included. The direct head-to-head diagnostic performance comparison showed higher sensitivity of Xpert Ultra in contrast with Xpert among 292 smear-negative pulmonary TB (PTB) (70.89% vs 57.88%, P = 0.001), 108 tuberculous pleurisy (61.11% vs 34.26%, P<0.001), and 43 tuberculous meningitis (44.19% vs 18.60%, P = 0.011). The percentage of definite PTB, tuberculous pleurisy and tuberculous meningitis increased from 67.12% to 78.77%, 61.11% to 69.44% and 23.26% to 51.16%, respectively after integrating Xpert Ultra outcomes. The specificity of Xpert Ultra and Xpert was 96.75% (238/246) and 98.37% (242/246), respectively. Xpert Ultra and Xpert performed similarly in detecting rifampicin resistance. Conclusion Xpert Ultra has higher sensitivity but relatively reduced specificity compared with Xpert in diagnosis of paucibacillary TB. Performing Xpert Ultra would improve the definite diagnosis of smear-negative pulmonary tuberculosis, tuberculous pleurisy and tuberculous meningitis.