Department of Health and Family Welfare, Government of Uttarakhand, Dehradun 248001, India.
Department of TB & Chest, Government Doon Medical College, Dehradun 248001, India.
Adv Respir Med. 2023 Jul 12;91(4):301-309. doi: 10.3390/arm91040024.
Tuberculosis (TB) affects a third of the global population, and a large population of infected individuals still remain undiagnosed-making the visible burden only the tip of the iceberg. The detection of tuberculosis in close-proximity patients is one of the key priorities for attaining the Sustainable Development Goals (SDG) of TB elimination by 2030. With the current battery of screening tests failing to cover this need, the authors of this paper examined a simple and inexpensive point-of-care breath analyzer (TSI-3000(I)), which is based on detecting the volatile organic compounds that are emitted from infected cells and released in exhaled breath as a screening tool for the detection of TB. A single-center pilot study for assessing the diagnostic accuracy of the point-of-care Tuberculosis Breath Analyzer was conducted, and it was compared against the WHO-recommended TrueNat assay, which is a rapid molecular test and was also treated as the reference standard in this study. Of the 334 enrolled participants with TB signs/symptoms, 42.51% were TrueNat positive for Mycobacterium tuberculosis. The sensitivity of the Tuberculosis Breath Analyzer was found to be 95.7%, with a specificity of 91.3% and a ROC area of 0.935. The test kit showed considerable/significant high sensitivity and specificity as reliability indicators. The performance of the Tuberculosis Breath Analyzer tested was found to be comparable in efficiency to that of the TrueNat assay. A large cohort-based multicentric study is feasibly required to further validate and extrapolate the results of the pilot study.
结核病（TB）影响了全球三分之一的人口，而大量受感染的人群仍未被诊断出来——可见的负担只是冰山一角。在接近患者的人群中检测结核病是实现到 2030 年消除结核病可持续发展目标（SDG）的关键优先事项之一。由于当前的一系列筛选测试无法满足这一需求，本文作者研究了一种简单且廉价的即时护理呼吸分析仪（TSI-3000(I)），它基于检测从感染细胞中释放并呼出的挥发性有机化合物，作为结核病检测的筛选工具。进行了一项评估即时护理结核病呼吸分析仪诊断准确性的单中心试点研究，并将其与世界卫生组织（WHO）推荐的 TrueNat 检测进行了比较，后者是一种快速分子检测，在本研究中也被视为参考标准。在有结核病迹象/症状的 334 名入组参与者中，42.51%的人对结核分枝杆菌呈 TrueNat 阳性。结果发现，结核病呼吸分析仪的敏感性为 95.7%，特异性为 91.3%，ROC 面积为 0.935。该测试试剂盒作为可靠性指标显示出相当/显著的高敏感性和特异性。测试的结核病呼吸分析仪的性能被发现与 TrueNat 检测的效率相当。需要进行大规模基于队列的多中心研究，以进一步验证和推断试点研究的结果。
