Siemens VOC TB Pilot Study
Siemens VOC TB Pilot Study
Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide.
 Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis
 require advanced and expensive diagnostic methods that restrict their availability in
 resource limited countries where the burden of tuberculosis is highest. The development of
 rapid point of care diagnostics is required.

 Published data confirm that trained African giant-pouched rats are able to identify M.
 tuberculosis cultures through olfactory recognition. A first trial using an electronic nose
 reported a rate of detection of 85% in tuberculosis patients. A further trial was closed in
 June 2011 but remains unpublished, yet. The olfactory pattern that potentially allows the
 recognition of tuberculosis remains unknown.

 This trial aims to detect first patterns of volatile organic compounds (VOCs) that bear a
 potential for further development and fine tuning. A technical prototypic device of Siemens
 is used for pattern detection.

 The study is comparing 3 groups of patients:

 -  patients with confirmed active pulmonary tuberculosis (n=20)

 -  patients with other inflammatory lung diseases (pneumonia, sarcoidosis, COPD, bronchial
 carcinoma) (n=20)

 -  healthy volunteers that do not work in the hospital or visit the hospital regularly
 Detailed data for all study subjects will be collected for this trial in order to
 eliminate confounding factors. Furthermore, detailed data of the surroundings of the
 patient, the surroundings of the technical device and of the operator will be captured.

 Hypothesis:

 The pattern of exhaled volatile organic compounds allows the detection of pulmonary
 tuberculosis
Inclusion Criteria:

 1. Confirmed pulmonary infection with M. tuberculosis (MTB) or other inflammatory disease
 of the lower respiratory tract (i.e. pneumonia, sarcoid, bronchial carcinoma) or
 healthy subject that is not employed or working at the study site

 2. Oral and written consent to study participation

 Exclusion Criteria:

 1. Tuberculosis therapy >1 week

 2. Inability to follow the study requirements

 3. Patient in custodianship or guardianship

 4. Other lung diseases that are not listed in the inclusion criteria.