Consultatie Implementatie Technisch Beheer B.V. (C-it), Marspoortstraat 2, 7201 JB Zutphen, The Netherlands.
Tuberculosis (Edinb). 2013 Mar;93(2):232-8. doi: 10.1016/j.tube.2012.10.002. Epub 2012 Nov 3.
Tuberculosis (TB), a highly infectious airborne disease, remains a major global health problem. Many of the new diagnostic techniques are not suited for operation in the highly-endemic low-income countries. A sensitive, fast, easy-to-operate and low-cost method is urgently needed. We performed a Proof of Principle Study (30 participants) and a Validation Study (194 participants) to estimate the diagnostic accuracy of a sophisticated electronic nose (DiagNose, C-it BV) using exhaled air to detect tuberculosis. The DiagNose uses a measurement method that enables transfer of calibration models between devices thus eliminating the most common pitfall for large scale implementation of electronic noses in general. DiagNose measurements were validated using traditional sputum smear microscopy and culture on Löwenstein-Jensen media. We found a sensitivity of 95.9% and specificity of 98.5% for the pilot study. In the validation study we found a sensitivity of 93.5% and a specificity of 85.3% discriminating healthy controls from TB patients, and a sensitivity of 76.5% and specificity of 87.2% when identifying TB patient within the entire test-population (best-case numbers). The portability and fast time-to-result of the DiagNose enables a proactive screening search for new TB cases in rural areas, without the need for highly-skilled operators or a hospital center infrastructure.
结核病（TB）是一种高度传染性的空气传播疾病，仍是全球主要的卫生问题之一。许多新的诊断技术并不适合在高度流行的低收入国家使用。因此，迫切需要一种灵敏、快速、易于操作且成本低廉的方法。我们进行了一项原理验证研究（30 名参与者）和一项验证研究（194 名参与者），以评估使用呼气来检测结核病的复杂电子鼻（DiagNose，C-it BV）的诊断准确性。DiagNose 使用一种测量方法，可以在设备之间转移校准模型，从而消除了电子鼻在大规模实施中最常见的陷阱。DiagNose 的测量结果使用传统的痰涂片显微镜检查和 Löwenstein-Jensen 培养基培养进行验证。我们在试点研究中发现，该方法的敏感性为 95.9%，特异性为 98.5%。在验证研究中，我们发现该方法在区分健康对照者和结核病患者时的敏感性为 93.5%，特异性为 85.3%，在识别整个测试人群中的结核病患者时的敏感性为 76.5%，特异性为 87.2%（最佳情况）。DiagNose 的便携性和快速结果可实现对农村地区新结核病病例的主动筛查，而无需高技能操作人员或医院中心基础设施。
