Li Yan, Pang Yu, Zhang Tianhua, Xian Xiaoping, Wang Xidi, Yang Jian, Wang Rui, Chen Meiling, Chen Wei
Clinical Laboratory, the First Affiliated Hospital, School of Medicine, Xi'an Jiaotong University, Xi'an 710061, PR China.
Clinical Laboratory, Shaanxi Provincial Institute for Tuberculosis Control and Prevention, Xi'an 710048, PR China.
J Med Microbiol. 2017 Jul;66(7):910-914. doi: 10.1099/jmm.0.000522. Epub 2017 Jul 15.
XpertMycobacterium tuberculosis/rifampicin (Xpert MTB/RIF) assay has been endorsed by the World Health Organization (WHO) for diagnosis of extrapulmonary tuberculosis (EPTB), while the sensitivity and specificity have not been fully evaluated. We aimed to evaluate the performance of Xpert MTB/RIF assay in the detection of different extrapulmonary specimens.
A total of 420 nonrespiratory specimens were detected with acid-fast bacilli (AFB) smear microscopy, solid culture, conventional drug susceptibility testing (DST) and Xpert MTB/RIF assay. Using solid culture and conventional DST as the gold standard, we assessed the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of the Xpert MTB/RIF assay for detecting MTB and rifampin resistance, respectively.
When setting the solid culture results as the gold standard, the sensitivity, specificity, PPV, NPV and Kappa value of Xpert MTB/RIF assay and AFB smear results were 70.6 % (48/68), 91.96 % (318/346), 63.2 % (48/76), 94.1 % (318/338), 0.60, respectively. In addition, when compared with conventional DST results, the sensitivity, specificity, PPV, NPV and Kappa of the Xpert MTB/RIF assay for detecting rifampin resistance were 91.7 % (11/12), 100.0 % (47/47), 100.0 % (11/11), 97.9 % (47/48) and 0.95, respectively.
Compared with AFB smear and solid culture, Xpert MTB/RIF assay has high sensitivities and short detection time, so could be used as an alternative for the rapid diagnosis of EPTB and rifampin resistance in clinical practice.
结核分枝杆菌/利福平Xpert检测法(Xpert MTB/RIF)已得到世界卫生组织(WHO)认可,用于肺外结核(EPTB)的诊断,但其敏感性和特异性尚未得到充分评估。我们旨在评估Xpert MTB/RIF检测法在检测不同肺外标本方面的性能。
采用抗酸杆菌(AFB)涂片显微镜检查、固体培养、传统药敏试验(DST)和Xpert MTB/RIF检测法对420份非呼吸道标本进行检测。以固体培养和传统DST作为金标准,我们分别评估了Xpert MTB/RIF检测法检测结核分枝杆菌(MTB)和利福平耐药性的敏感性、特异性、阳性预测值(PPV)、阴性预测值(NPV)。
以固体培养结果作为金标准时,Xpert MTB/RIF检测法和AFB涂片结果的敏感性、特异性、PPV、NPV和Kappa值分别为70.6%(48/68)、91.96%(318/346)、63.2%(48/76)、94.1%(318/338)、0.60。此外,与传统DST结果相比,Xpert MTB/RIF检测法检测利福平耐药性的敏感性、特异性、PPV、NPV和Kappa值分别为91.7%(11/12)、100.0%(47/47)、100.0%(11/11)、97.9%(47/48)和0.95。
与AFB涂片和固体培养相比,Xpert MTB/RIF检测法具有较高的敏感性和较短的检测时间,因此在临床实践中可作为EPTB和利福平耐药性快速诊断的替代方法。