Department of Clinical Laboratory, Zhengzhou Orthopaedics Hospital, Zhengzhou, Henan 450000, PR China.
Department of Pathology, Zhengzhou Orthopaedics Hospital, Zhengzhou, Henan 450000, PR China.
Clin Biochem. 2020 Nov;85:33-37. doi: 10.1016/j.clinbiochem.2020.08.010. Epub 2020 Aug 25.
Xpert MTB/RIF is recommended to detect pulmonary tuberculosis; however, there is insufficient data on its utility for bone samples. This study aimed to assess the accuracy of Xpert MTB/RIF compared with conventional histopathology in diagnosing spinal tuberculosis (STB) based on bone specimens in high burden settings.
Totally, 128 suspected STB participants were enrolled into this study. The bone specimens were obtained through puncture or operation for histological and Xpert MTB/RIF analyses, so as to compare their accuracy in diagnosing STB by the composite reference standard (CRS).
Finally, 106 subjects with suspected STB were recruited into the analysis, including 27 confirmed and 33 clinically diagnosed STB patients. Relative to histopathology, Xpert MTB/RIF achieved a 86.7% sensitivity, and 12 out of 30 STB patients were positive, while the negative results in them were obtained upon histopathology. Based on CRS, Xpert MTB/RIF yielded a 63.3% sensitivity, which significantly elevated relative to that obtained upon histopathological test (50.0%, p < 0.001). In addition, the pooled sensitivity obtained using the above 2 approaches was as high as 95.0%, which was higher than that of any of the 2 approaches alone. The pooled specificity was 97.8%. Moreover, the area under the curve (AUC) value was 0.75 for Xpert MTB/RIF and 0.81 for histopathology, with no statistical significance. The two methods showed moderate concordance in the diagnosis of STB.
The Xpert MTB/RIF test achieves superior specificity and fair sensitivity, which can not be recommended to replace the conventional examinations for the diagnosis of STB. The combined application of these 2 approaches can improve the pooled diagnostic sensitivity and accuracy for STB.
Xpert MTB/RIF 被推荐用于检测肺结核,但关于其在骨标本中检测骨结核(STB)的效用的数据不足。本研究旨在评估 Xpert MTB/RIF 与常规组织病理学相比,在高负担地区基于骨标本诊断 STB 的准确性。
共纳入 128 例疑似 STB 患者进行本研究。通过穿刺或手术获取骨标本,进行组织学和 Xpert MTB/RIF 分析,以复合参考标准(CRS)比较两种方法诊断 STB 的准确性。
最终纳入 106 例疑似 STB 患者进行分析,包括 27 例确诊和 33 例临床诊断的 STB 患者。与组织病理学相比,Xpert MTB/RIF 的敏感性为 86.7%,30 例 STB 患者中有 12 例阳性,而组织病理学检查结果为阴性。基于 CRS,Xpert MTB/RIF 的敏感性为 63.3%,明显高于组织病理学检查(50.0%,p<0.001)。此外,上述两种方法联合应用的敏感性高达 95.0%,高于两种方法中的任何一种单独应用的敏感性。总体特异性为 97.8%。此外,Xpert MTB/RIF 的曲线下面积(AUC)值为 0.75,组织病理学的 AUC 值为 0.81,差异无统计学意义。两种方法对 STB 的诊断具有中等一致性。
Xpert MTB/RIF 试验具有较高的特异性和适度的敏感性,不能推荐用于替代常规检查来诊断 STB。联合应用这两种方法可以提高 STB 的联合诊断敏感性和准确性。