<b><span style="font-family:Verdana;">Background:</span></b><span style="font-family:Verdana;"> Extrapulmonary tuberculosis (EPTB) remains difficult to diagnose becaus...<b><span style="font-family:Verdana;">Background:</span></b><span style="font-family:Verdana;"> Extrapulmonary tuberculosis (EPTB) remains difficult to diagnose because the clinical specimens to be examined are often paucibacillary</span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;"> and obtained with difficulty from inaccessible sites. </span><span style="font-family:Verdana;">An updated Xpert<sup></sup></span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"><sup><span style="white-space:nowrap;">®</span></sup></span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> MTB/RIF Ultra (Ultra) test has been designed and licensed to improve sensitivity in the detection of Mycobacterium tuberculosis complex.</span></span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;"> The aim of the present study is to evaluate the performance of Ultra assay for the clinical diagnosis of EPTB in </span><span style="font-family:Verdana;">a low tuberculosis prevalence country. </span><span style="font-family:Verdana;"><b></b></span><b><b><span style="font-family:Verdana;">Methods:</span></b><span style="font-family:Verdana;"></span></b></span><span style="font-family:Verdana;"> A retrospective analysis was performed at “A.</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;">O dei Colli” of Naples on consecutive extrapulmonary specimens for EPTB across a three-year period. All different types of extrapulmonary specimens were tested for EPTB by smear microscopy, culture and Ultra assay in accordance with relevant guidelines. </span><span style="font-family:Verdana;"><b></b></span><b><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"></span></b></span><b> </b><span style="font-family:Verdana;">A total of 606 EPTB samples, 561 culture negative EPTB and 45 culture positive EPTB were included. Using culture as reference standard, the overall sensitivities and specificities of Ultra assay were 95.6% (95% CI 84.8</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">-</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">99.5) and 97.5% (95% CI 95.8</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">-</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">98.6) respectively. Sensitivity and specificity of Ultra for individual category of specimens w</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">ere</span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;"> also</span><span style="color:red;"> </span><span style="font-family:Verdana;">performed. </span><span style="font-family:Verdana;"><b></b></span><b><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"></span></b></span><span style="font-family:Verdana;"> In a </span><span style="font-family:Verdana;">low-tuberculosis prevalence setting, Ultra assay confirms to have a good performance in the diagnosis of EPTB for all different extrapulmonary samples.</span></span></span>展开更多
文摘<b><span style="font-family:Verdana;">Background:</span></b><span style="font-family:Verdana;"> Extrapulmonary tuberculosis (EPTB) remains difficult to diagnose because the clinical specimens to be examined are often paucibacillary</span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;"> and obtained with difficulty from inaccessible sites. </span><span style="font-family:Verdana;">An updated Xpert<sup></sup></span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"><sup><span style="white-space:nowrap;">®</span></sup></span></span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;"> MTB/RIF Ultra (Ultra) test has been designed and licensed to improve sensitivity in the detection of Mycobacterium tuberculosis complex.</span></span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;"> The aim of the present study is to evaluate the performance of Ultra assay for the clinical diagnosis of EPTB in </span><span style="font-family:Verdana;">a low tuberculosis prevalence country. </span><span style="font-family:Verdana;"><b></b></span><b><b><span style="font-family:Verdana;">Methods:</span></b><span style="font-family:Verdana;"></span></b></span><span style="font-family:Verdana;"> A retrospective analysis was performed at “A.</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;">O dei Colli” of Naples on consecutive extrapulmonary specimens for EPTB across a three-year period. All different types of extrapulmonary specimens were tested for EPTB by smear microscopy, culture and Ultra assay in accordance with relevant guidelines. </span><span style="font-family:Verdana;"><b></b></span><b><b><span style="font-family:Verdana;">Results:</span></b><span style="font-family:Verdana;"></span></b></span><b> </b><span style="font-family:Verdana;">A total of 606 EPTB samples, 561 culture negative EPTB and 45 culture positive EPTB were included. Using culture as reference standard, the overall sensitivities and specificities of Ultra assay were 95.6% (95% CI 84.8</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">-</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">99.5) and 97.5% (95% CI 95.8</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">-</span></span></span><span><span><span style="font-family:;" "=""> </span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">98.6) respectively. Sensitivity and specificity of Ultra for individual category of specimens w</span></span></span><span style="font-family:Verdana;"><span style="font-family:Verdana;"><span style="font-family:Verdana;">ere</span></span></span><span><span><span style="font-family:;" "=""><span style="font-family:Verdana;"> also</span><span style="color:red;"> </span><span style="font-family:Verdana;">performed. </span><span style="font-family:Verdana;"><b></b></span><b><b><span style="font-family:Verdana;">Conclusion:</span></b><span style="font-family:Verdana;"></span></b></span><span style="font-family:Verdana;"> In a </span><span style="font-family:Verdana;">low-tuberculosis prevalence setting, Ultra assay confirms to have a good performance in the diagnosis of EPTB for all different extrapulmonary samples.</span></span></span>