ENOSE in Pulmonary Tuberculosis in Yogyakarta (YOGYATBNOSE)

The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients

Electronic noses detecting patterns of volatile molecules have recently been introduced for different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%. Here the investigators test a production type point-of-care hand-held device with less detectors. The investigators explore factors such as food intake, smoking, and co-morbidity, as well as the impact of TB treatment, and address the question whether the device could help monitor disease and response to treatment.

Study participants provide WIC and after time for consideration, when they approve, provide demographic anonymized data. The study population consists of six groups: Group 1 - 20 TB patients aged > 18 yrs Group 2 - 20 non---TB patients > 18 yrs (screened for TB - other conditions) Group 3 - 20 patients with a lung disease - no TB suspects (Lung Clinics in Yogyakarta,Indonesia; Group 4 - 50 apparently healthy matched controls Group 5 - 20 newly diagnosed TB patients enrolled before start of treatment, to be followed over time, until after end of treatment (8 months FU). Group 6 - 50 apparently healthy volunteers. Study participants breath normally by mouthpiece into the device using a nose clamp - for 5 min during each sampling. Electronic data are downloaded and transmitted by internet to Zutphen, Netherlands where data are processed to build the model.

Pulmonary Tuberculosis Suspected, Other Specified Chronic Obstructive Pulmonary Disease, Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology

6 groups: 1) 20 TB patients 2) 20 non-TB patients (alternative diagnosis) 3) 20 patients with chest symptoms - non-TB 4) 7 MDR-TB patients 5) 20 healthy controls 6) 300 subjects suspected to have pulmonary tuberculosis - follow-up for 2.5 years

Group 2 - 20 non-TB patients > 18 yrs (screened for TB - but appear to test negative for TB, and diagnosed with other conditions including bronchiectasis, etc) 5 min exhaled breath sampling with nose clamp

Group 3 - 20 patients with a lung disease - no TB suspects (recruited from Lung Clinics in Yogyakarta; lung cancer, COPD, etc) 5 min exhaled breath sampling with nose clamp

Group 5 - 7 newly diagnosed MDRTB patients enrolled before start of treatment, to be followed 8 months, until after end of treatment 5 min exhaled breath sampling with nose clamp

300 more individuals, suspected to have TB - final diagnosis by standard procedures plus sputum culture plus follow-up for >2 years 5 min exhaled breath sampling with nose clamp

study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc

sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB

cohort of patients newly deteted with PTB will be followed with the enose device over time to monitor disease activity, until end of treatment

patients - at 5 lung clinics (Minggiran, Kalasan, Kotagede, Bantul, Kuonprogo) connected with Sudjarto Teachnig Hospital; healthy controls among students and staff of Hospital and Gadjah Mada Universitas

Saktiawati AMI, Subronto YW, Stienstra Y, Sumardi, Supit F, van der Werf TS. Sensitivity and specificity of routine diagnostic work-up for tuberculosis in lung clinics in Yogyakarta, Indonesia: a cohort study. BMC Public Health. 2019 Apr 2;19(1):363. doi: 10.1186/s12889-019-6658-8.