Abstract
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). 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. 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 Ul...Continue Reading
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