eNose-TB: Electronic Nose for Tuberculosis Screening

An electronic-nose (e-nose) had been investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis.

The study population consists of 2 groups: Group 1 - presumptive TB patients. Group 2 - residents of area with high risk of TB. Study participants provide written informed consent. The participants are asked to breathe normally using a mask for 2 times then inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full (two times). The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter protecting the e-nose from microbes. The breath pattern will be recorded in the e-nose device, which is connected to a laptop that will display the recorded breath pattern. Other data are collected: clinical symptoms, results of chest X-ray, smear microscopic, and Xpert MTB/Rif examinations.

The Validation phase involves suspected TB patients (Group 1) and the Screening phase involves residents of area with high risk of TB (Group 2)

The study use a triple-blind masking, in which the research subjects, breath sample takers, and laboratory sample examiners do not know the results of each sampling that has been done. The final data processor is also blinded to the results of Xpert or other laboratory examinations. The breath sampling data is saved in graphic form which interpretation will be carried out later by the data processor at the final stage.

The participants breathe normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full.

The participants breathe normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume to the air collecting bag until the collecting bag is full.

The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine.

The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine.

sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB

- Inclusion Criteria: Validation Phase (Group 1): Adult and children Suspected of having TB Agree to participate in the study Able to produce exhaled air samples Able to produce samples for Xpert MTB/Rif examination Screening Phase (Group 2): Adult and children Agree to participate in the study Able to produce exhaled air samples Currently not in TB treatment - Exclusion Criteria Invalid measurements of breath tests Incomplete CXR data Missing specimens Unable to breath normally for 2 minutes due to respiratory illness

Saktiawati AMI, Triyana K, Wahyuningtias SD, Dwihardiani B, Julian T, Hidayat SN, Ahmad RA, Probandari A, Mahendradhata Y. eNose-TB: A trial study protocol of electronic nose for tuberculosis screening in Indonesia. PLoS One. 2021 Apr 21;16(4):e0249689. doi: 10.1371/journal.pone.0249689. eCollection 2021.