Clinical performance of automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance assay in diagnosis of pulmonary tuberculosis in 214 cases / 中华传染病杂志

ABSTRACT

Objective To evaluate the clinical application of the automated nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance (Xpert M TB/RIF) in diagnosis of pulmonary tuberculosis in Wenzhou .Methods A total of 214 patients with suspected pulmonary tuberculosis , clinical diagnosed tuberculosis or suspected drug‐resistant tuberculosis were enrolled in this study .The patients′ sputum specimens were collected for acid‐fast smear ,liquid culture and Xpert M TB/RIF assay .The sensitivity and specificity of three tests for the detection of mycobacterium tuberculosis (M TB) were determined using the clinical final diagnosis as golden standard .The sensitivity and specificity of Xpert M TB /RIF for the detection of rifampin resistance were determined using liquid drug susceptibility as the golden standard .The sensitivity and specificity were compared using chi‐squared test .Results Using the clinical final diagnosis as golden standard ,Xpert M TB/RIF had significantly higher sensitivity than sputum acid‐fast smear (69 .5% vs 44 .1% , χ2 = 23 .31 ,P 0 .05) .The sensitivities of Xpert M TB /RIF in smear positive and smear negative M TB samples were 97 .4% and 47 .5% ,respectively ;the specificities in smear positive and smear negative M TB samples were both 100 .0% .The sensitivity and specificity of Xpert M TB /RIF for the detection of rifampin resistance were 92 .9% and 98 .8% ,respectively using the liquid drug susceptibility test as golden standard .Conclusions Xpert M TB/RIF can detect M TB and rifampin resistance rapidly and accurately with higher sensitivity ,which is highly valuable in practical application .