title: Diagnosis of active tuberculosis by e-nose analysis of exhaled air.
abstract: 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.
authors.affiliation: Consultatie Implementatie Technisch Beheer B.V. (C-it), Marspoortstraat 2, 7201 JB Zutphen, The Netherlands. Marcel.Bruins@eNose.nl
authors.forename: Marcel
authors.initials: M
authors.lastname: Bruins
authors.forename: Zeaur
authors.initials: Z
authors.lastname: Rahim
authors.forename: Albert
authors.initials: A
authors.lastname: Bos
authors.forename: Wendy W J
authors.initials: WW
authors.lastname: van de Sande
authors.forename: Hubert Ph
authors.initials: HP
authors.lastname: Endtz
authors.forename: Alex
authors.initials: A
authors.lastname: van Belkum
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001944:Breath Tests / Q000379:methods; D003906:Developing Countries; D062609:Electronic Nose; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*; D055815:Young Adult