Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
University of Basel, Basel, Switzerland.
Microbiol Spectr. 2024 Jun 4;12(6):e0042624. doi: 10.1128/spectrum.00426-24. Epub 2024 May 8.
Tuberculosis (TB) caused by () remains one of the deadliest infectious diseases globally. Timely diagnosis is a key step in the management of TB patients and in the prevention of further transmission events. Current diagnostic tools are limited in these regards. There is an urgent need for new accurate non-sputum-based diagnostic tools for the detection of symptomatic as well as subclinical TB. In this study, we recruited 52 symptomatic TB patients (sputum Xpert MTB/RIF positive) and 58 household contacts to assess the accuracy of a sequence-specific hybridization assay that detects the presence of cell-free DNA in urine. Using sputum Xpert MTB/RIF as a reference test, the magnetic bead-capture assay could discriminate active TB from healthy household contacts with an overall sensitivity of 72.1% [confidence interval (CI) 0.59-0.86] and specificity of 95.5% (CI 0.90-1.02) with a positive predictive value of 93.9% and negative predictive value of 78.2%. The detection of -specific DNA in urine suggested four asymptomatic TB infection cases that were confirmed in all instances either by concomitant Xpert MTB/RIF sputum testing or by follow-up investigation raising the specificity of the index test to 100%. We conclude that sequence-specific hybridization assays on urine specimens hold promise as non-invasive tests for the detection of subclinical TB.
There is an urgent need for a non-sputum-based diagnostic tool allowing sensitive and specific detection of all forms of tuberculosis (TB) infections. In that context, we performed a case-control study to assess the accuracy of a molecular detection method enabling the identification of cell-free DNA from that is shed in the urine of tuberculosis patients. We present accuracy data that would fulfill the target product profile for a non-sputum test. In addition, recent epidemiological data suggested that up to 50% of individuals secreting live bacilli do not present with symptoms at the time of screening. We report, here, that the investigated index test could also detect instances of asymptomatic TB infections among household contacts.
仍然由 引起的结核病（TB）是全球最致命的传染病之一。及时诊断是管理 TB 患者和预防进一步传播事件的关键步骤。目前的诊断工具在这些方面存在局限性。迫切需要新的准确的非痰基诊断工具来检测有症状和亚临床 TB。在这项研究中，我们招募了 52 名有症状的 TB 患者（Xpert MTB/RIF 阳性痰）和 58 名家庭接触者，以评估一种检测尿液中 游离 DNA 存在的序列特异性杂交检测的准确性。使用 Xpert MTB/RIF 作为参考测试，磁珠捕获检测可以将活动性 TB 与健康的家庭接触者区分开来，总敏感性为 72.1%（置信区间 [CI] 0.59-0.86），特异性为 95.5%（CI 0.90-1.02），阳性预测值为 93.9%，阴性预测值为 78.2%。尿液中 - 特异性 DNA 的检测提示有 4 例无症状 TB 感染病例，所有这些病例均通过同时进行的 Xpert MTB/RIF 痰检测或后续调查得到证实，从而将该指标检测的特异性提高到 100%。我们得出结论，尿液标本上的序列特异性杂交检测具有作为亚临床 TB 非侵入性检测的潜力。
迫切需要一种非痰基诊断工具，能够敏感且特异性地检测所有形式的结核病（TB）感染。在这种情况下，我们进行了一项病例对照研究，以评估一种分子检测方法的准确性，该方法能够识别从 中释放到结核病患者尿液中的游离 DNA。我们提供了满足非痰检测目标产品概况的准确性数据。此外，最近的流行病学数据表明，多达 50%的分泌活菌的个体在筛查时没有出现症状。我们报告，所研究的指标检测还可以检测家庭接触者中的无症状 TB 感染病例。
