Department of Pulmonary Medicine, Christian Medical College, Vellore, India.
Department of General Surgery - Unit IV, Christian Medical College, Vellore, India.
Int J Tuberc Lung Dis. 2021 Nov 1;25(11):939-944. doi: 10.5588/ijtld.21.0280.
Extrapulmonary TB (EPTB) comprises approximately 15-20% of TB cases worldwide, and its diagnosis is difficult. The sensitivity of Xpert MTB/RIF (Xpert) in the diagnosis of EPTB is low on account of its paucibacillary nature. Xpert MTB/RIF Ultra (Ultra) was developed to improve sensitivity. To compare the sensitivity of Ultra test with that of Xpert against MGIT™ (Mycobacteria Growth Indicator Tube) culture and a composite reference standard (CRS). We recruited consecutive treatment-naïve patients with suspected EPTB. Demographic information, clinical and relevant laboratory data were collected. From January 2019 to November 2019, 210 patients provided 250 samples. Against MGIT culture, the sensitivity of Ultra was significantly higher than Xpert (72% vs. 51.1%; = 0.04), the specificity was lower (87.8% vs. 95.1%). Against the CRS also, the sensitivity of Ultra was significantly higher than Xpert (45.4% vs. 25.2%; = 0.002); however, the specificities were similar (98.2% vs. 99.1%). The trend towards higher sensitivity of Ultra compared to Xpert was seen in most of the individual samples. The sensitivities against MGIT and CRS were as follows: lymph node (68.1% vs. 31.8%; = 0.01) and (59.5% vs. 23.8%; = 0.001), pleural biopsy (80.0% on both; = NS) and (53.8% vs. 46.2%; = NS) and pleural fluid (66.7% vs. 50%; = NS) and (22.5% vs. 9.6%; = NS), respectively. Xpert Ultra showed a significantly higher sensitivity in diagnosing EPTB than Xpert.
肺外结核（EPTB）约占全球结核病例的 15-20%，其诊断较为困难。由于其菌量少，Xpert MTB/RIF（Xpert）检测对 EPTB 的诊断灵敏度较低。Xpert MTB/RIF Ultra（Ultra）的开发是为了提高灵敏度。本研究旨在比较 Ultra 试验与 Xpert 检测对 MGIT 培养和复合参考标准（CRS）的敏感性。我们连续招募了疑似 EPTB 的初治患者。收集了人口统计学信息、临床和相关实验室数据。2019 年 1 月至 11 月，210 名患者提供了 250 份样本。与 MGIT 培养相比，Ultra 的灵敏度显著高于 Xpert（72% vs. 51.1%； = 0.04），特异性较低（87.8% vs. 95.1%）。与 CRS 相比，Ultra 的灵敏度也显著高于 Xpert（45.4% vs. 25.2%； = 0.002）；然而，特异性相似（98.2% vs. 99.1%）。与 Xpert 相比，Ultra 的灵敏度在大多数单个样本中都有较高的趋势。针对 MGIT 和 CRS 的灵敏度如下：淋巴结（68.1% vs. 31.8%； = 0.01）和（59.5% vs. 23.8%； = 0.001），胸膜活检（均为 80.0%； = NS）和（53.8% vs. 46.2%； = NS），胸腔积液（66.7% vs. 50%； = NS）和（22.5% vs. 9.6%； = NS）。Xpert Ultra 检测在诊断 EPTB 方面的灵敏度明显高于 Xpert。
