The Xpert MTB/RIF Ultra is a recent advancement in molecular diagnostics of tuberculosis (TB) with higher sensitivity compared to its predecessor, the Xpert MTB/RIF assay. Prospective studies evaluating the performance of Xpert MTB/RIF Ultra in children with suspected TB are lacking. In this study, we evaluated the Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis in samples from 156 children, of which one was excluded from the analysis. Of the remaining 155 samples, 6.5% (10/155), 21.3% (33/155), 20% (31/155) and 21.9% (34/155) were positive by smear examination, MGIT culture, Xpert MTB/RIF and Xpert MTB/RIF Ultra, respectively. The Xpert MTB/RIF and Xpert MTB/RIF Ultra had a similar overall sensitivity of 81.8% (95% CI: 64.5-93) and 84.8% (95% CI: 68.1-94.9), respectively. In suspected pediatric TB patients, the Xpert MTB/RIF Ultra had higher sensitivity compared to the Xpert MTB/RIF (72.7 vs 63.6). The AUC (area under the curve) of 0.905 for the Xpert MTB/RIF and 0.893 for the Xpert MTB/RIF Ultra indicate similar and good overall performance. Both Xpert assays were found to be equally efficient, however Xpert MTB/RIF Ultra showed better detection rate in suspected TB cases.

中文翻译：

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Xpert MTB/RIF Ultra 检测儿童结核分枝杆菌的诊断准确性：一项前瞻性队列研究。

Xpert MTB/RIF Ultra 是结核病 (TB) 分子诊断的最新进展，与其前身 Xpert MTB/RIF 检测相比具有更高的灵敏度。缺乏评估 Xpert MTB/RIF Ultra 在疑似结核病儿童中的表现的前瞻性研究。在这项研究中，我们评估了 Xpert MTB/RIF Ultra 在 156 名儿童样本中检测结核分枝杆菌的能力，其中一个被排除在分析之外。其余 155 个样本中，6.5% (10/155)、21.3% (33/155)、20% (31/155) 和 21.9% (34/155) 涂片检查、MGIT 培养、Xpert MTB/RIF 呈阳性和 Xpert MTB/RIF Ultra。Xpert MTB/RIF 和 Xpert MTB/RIF Ultra 的总体灵敏度相似，分别为 81.8%（95% CI：64.5-93）和 84.8%（95% CI：68.1-94.9）。在疑似儿童结核病患者中，与 Xpert MTB/RIF 相比，Xpert MTB/RIF Ultra 具有更高的灵敏度（72.7 对 63.6）。Xpert MTB/RIF 的 AUC（曲线下面积）为 0.905，Xpert MTB/RIF Ultra 的 AUC（曲线下面积）为 0.893，表明整体性能相似且良好。发现两种 Xpert 检测的效率相同，但 Xpert MTB/RIF Ultra 在疑似结核病病例中显示出更好的检出率。