Wang Sheng Fen, Ou Xi Chao, Li Qiang, Zheng Hui Wen, Wang Yu Feng, Zhao Yan Lin
National Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, 155 Changbai Rd, Beijing 102206, PR China.
National Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, 155 Changbai Rd, Beijing 102206, PR China.
Int J Infect Dis. 2016 Apr;45:78-80. doi: 10.1016/j.ijid.2016.02.024. Epub 2016 Mar 3.
To evaluate the performance of the newly developed technology Abbott RealTime MTB assay (RealTime MTB assay) for the detection of Mycobacterium tuberculosis in sputum specimens and to compare its performance with that of the Cepheid GeneXpert assay.
Sputum specimens were collected from 270 subjects suspected to have tuberculosis (TB). Smear microscopy, culture, identification, RealTime MTB, and GeneXpert assays were performed according to standard protocols. Accuracy measures of the method evaluated were determined using solid culture as the reference standard.
The RealTime MTB assay showed similar positive detection rates as the GeneXpert assay in smear-positive, culture-positive, and smear/culture-negative groups; no significant differences were found in these groups between the two assays. The RealTime MTB assay demonstrated a sensitivity of 100% and a specificity of 84.4%; the GeneXpert assay had a sensitivity of 96.9% and specificity of 89.6%. After the resolution of discordant results by PCR-based molecular method, the sensitivities and specificities of the RealTime MTB and GeneXpert assays were 100% vs. 97% and 90.0% vs. 95.6%, respectively; no significant difference in sensitivity or specificity was found between the RealTime MTB and GeneXpert assays.
This study demonstrated that the Abbott RealTime MTB and Cepheid GeneXpert assays have similar sensitivity and specificity. The Abbott RealTime MTB assay is a highly promising method for the diagnosis of TB.
评估新开发的雅培实时结核分枝杆菌检测法（实时结核分枝杆菌检测法）在痰标本中检测结核分枝杆菌的性能，并将其性能与赛沛GeneXpert检测法进行比较。
从270名疑似患有结核病（TB）的受试者中收集痰标本。按照标准方案进行涂片显微镜检查、培养、鉴定、实时结核分枝杆菌检测和GeneXpert检测。以固体培养作为参考标准，确定所评估方法的准确性指标。
在涂片阳性、培养阳性和涂片/培养阴性组中，实时结核分枝杆菌检测法的阳性检出率与GeneXpert检测法相似；两组检测方法在这些组中未发现显著差异。实时结核分枝杆菌检测法的灵敏度为100%，特异性为84.4%；GeneXpert检测法的灵敏度为96.9%，特异性为89.6%。通过基于聚合酶链反应的分子方法解决不一致结果后，实时结核分枝杆菌检测法和GeneXpert检测法的灵敏度和特异性分别为100%对97%和90.0%对95.6%；实时结核分枝杆菌检测法和GeneXpert检测法在灵敏度或特异性方面未发现显著差异。
本研究表明，雅培实时结核分枝杆菌检测法和赛沛GeneXpert检测法具有相似的灵敏度和特异性。雅培实时结核分枝杆菌检测法是一种极有前景的结核病诊断方法。
