eNose-TB: Electronic Nose for Tuberculosis Screening

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia

Conditions
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Tuberculosis

Intervention / Treatment
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* Other: exhaled breath sampling
* Other: exhaled breath sampling


Participation Criteria
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Eligibility Criteria
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- 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

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The Validation phase involves suspected TB patients (Group 1) and the Screening phase involves residents of area with high risk of TB (Group 2)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Presumptive TB patients (395 participants - adult and children)<br>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. | Other: exhaled breath sampling<br>* 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.<br>* Other names: GeNose exhaled breath sampling;|
| Experimental: Residents of area with high risk of TB (1383 participants - adult and children)<br>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. | Other: exhaled breath sampling<br>* 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.<br>* Other names: GeNose exhaled breath sampling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of electronic nose signal in tuberculosis | sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic-nose, breath test, tuberculosis, screening