Xpert MTB/RIF assay 对组织标本骨关节结核的诊断准确性。
Diagnostic accuracy of the Xpert MTB/RIF assay for bone and joint tuberculosis using tissue specimens.
机构信息
Department of Clinical Laboratory, Zhengzhou Orthopaedics Hospital, Zhengzhou, Henan, 450000, PR China.
Department of Clinical Laboratory, Zhengzhou Orthopaedics Hospital, Zhengzhou, Henan, 450000, PR China.
出版信息
Int J Infect Dis. 2021 Apr;105:224-229. doi: 10.1016/j.ijid.2021.02.030. Epub 2021 Feb 12.
OBJECTIVES
To evaluate the diagnostic accuracy of the Xpert MTB/RIF assay for bone and joint tuberculosis (BJTB) using tissue specimens, and to compare the diagnostic accuracy of different types of tissue specimens.
METHODS
This study involved 242 patients admitted with suspected BJTB between May 2018 and March 2020. The Xpert MTB/RIF assay was performed on surgically excised tissue. Diagnostic accuracy of the Xpert MTB/RIF assay was evaluated by culture, histopathology and a composite reference standard (CRS).
RESULTS
One hundred and seventy-five patients were excluded (91 based on the exclusion criteria, and 84 as pus specimens were used instead of tissue specimens). Of the 67 patients enrolled, 14 were confirmed as BJTB, 20 as probable BJTB, 11 as possible BJTB, and 22 as non-BJTB. Using culture as the reference standard, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), negative likelihood ratio (NLR) and area under the curve (AUC) of the Xpert MTB/RIF assay were 92.9% (88.2-97.6%), 62.3% (56.1-68.5%), 39.4% (33.2-45.6%), 97.1% (92.3-100.0%), 2.464 (1.077-3.851), 0.114 (0.025-0.203) and 0.776 (0.654-0.897), respectively. When histopathology was used as the reference standard, the Xpert MTB/RIF assay had sensitivity, specificity, PPV, NPV, PLR, NLR and AUC of 79.3% (73.5-85.1%), 73.7% (67.8-79.6%), 69.7% (63.8-75.6%), 82.4% (76.5-88.3%), 3.015 (1.184-4.846), 0.281 (0.141-0.421) and 0.765 (0.646-0.884), respectively. Sensitivity, specificity, PPV, NPV, PLR, NLR and AUC obtained when using CRS as the reference were 73.3% (67.9-78.7%), 100.0% (100.0-100.0%), 100.0% (100.0-100.0%), 64.7% (58.5-70.9%), +∞, 0.267 (0.129-0.405) and 0.867 (0.781-0.952), respectively. Tissue samples were classified, and the positive rate of the Xpert MTB/RIF assay for BJTB using granulation tissue specimens was found to be significantly higher than that for caseous necrotic tissue, sequestrum and other necrotic connective tissues (P < 0.05).
CONCLUSION
The Xpert MTB/RIF assay showed high sensitivity and specificity for the diagnosis of BJTB from tissue specimens.
目的
评估 Xpert MTB/RIF assay 检测骨与关节结核（BJTB）组织标本的诊断准确性，并比较不同类型组织标本的诊断准确性。
方法
本研究纳入了 2018 年 5 月至 2020 年 3 月间疑似 BJTB 住院的 242 例患者。对手术切除的组织进行 Xpert MTB/RIF assay 检测。通过培养、组织病理学和综合参考标准（CRS）评估 Xpert MTB/RIF assay 的诊断准确性。
结果
175 例患者被排除（91 例基于排除标准，84 例为脓液标本代替组织标本）。在纳入的 67 例患者中，14 例被确诊为 BJTB，20 例为疑似 BJTB，11 例为可能 BJTB，22 例为非 BJTB。以培养为参考标准，Xpert MTB/RIF assay 的敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）、阳性似然比（PLR）、阴性似然比（NLR）和曲线下面积（AUC）分别为 92.9%（88.2-97.6%）、62.3%（56.1-68.5%）、39.4%（33.2-45.6%）、97.1%（92.3-100.0%）、2.464（1.077-3.851）、0.114（0.025-0.203）和 0.776（0.654-0.897）。当以组织病理学为参考标准时，Xpert MTB/RIF assay 的敏感性、特异性、PPV、NPV、PLR、NLR 和 AUC 分别为 79.3%（73.5-85.1%）、73.7%（67.8-79.6%）、69.7%（63.8-75.6%）、82.4%（76.5-88.3%）、3.015（1.184-4.846）、0.281（0.141-0.421）和 0.765（0.646-0.884）。以 CRS 为参考标准时，Xpert MTB/RIF assay 的敏感性、特异性、PPV、NPV、PLR、NLR 和 AUC 分别为 73.3%（67.9-78.7%）、100.0%（100.0-100.0%）、100.0%（100.0-100.0%）、64.7%（58.5-70.9%）、+∞、0.267（0.129-0.405）和 0.867（0.781-0.952）。对组织标本进行分类，发现使用肉芽组织标本的 Xpert MTB/RIF assay 对 BJTB 的阳性率明显高于干酪样坏死组织、死骨和其他坏死性结缔组织（P < 0.05）。
结论
Xpert MTB/RIF assay 对组织标本 BJTB 的诊断具有较高的敏感性和特异性。
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