eNose-TB: Electronic Nose for Tuberculosis Screening

eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia

An electronic-nose (e-nose) is being 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 particularly in remote area. Various factors (gender, age, race, and location) are considered in the algorithm training to develop an inclusive eNose. Access barriers, especially those faced by women, are also assessed.

Study Overview

• Status: Active, not recruiting
• Conditions: Tuberculosis
• Intervention / Treatment: Other: exhaled breath sampling

Detailed Description

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.

Demographic (gender, age, race, and location) and clinical data (symptoms, physical examination, laboratory examinations) are collected. Access barriers, especially for women, are also assessed through questionnaire and interviews.

• Study Type: Interventional
• Enrollment (Actual): 1778
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Klaten, Central Java, Indonesia, 50131
      • Balai Kesehatan Masyarakat Klaten
  • Daerah Istimewa Yogyakarta
    • Yogyakarta, Daerah Istimewa Yogyakarta, Indonesia
      • Primary health centers and hospital
  • Papua
    • Timika, Papua, Indonesia
      • Primary health centers and hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

- 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Presumptive TB patients and residents of area with high risk of TB; Presumptive TB patients consists of 395 participants - adult and children, while Residents of area with high risk of TB consists of 1383 participants - adult and children)	Other: exhaled breath sampling; 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.; Other Names: GeNose exhaled breath sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of electronic nose signal in screening tuberculosis that is measured through sensitivity, specificity, PPV, NPV	sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB, factors influencing the diagnostic accuracy	2 years
Access barriers, measured through questionnaire, interview, and focus group discussion	access barriers to the TB screening that are measured through questionnaire, interview, and focus group discussion	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of a screening algorithm with eNose-TB, measured in days	Time of a screening algorithm with eNose-TB to obtain additional detection of one TB case, measured in days	2 years

Collaborators and Investigators

• Sponsor: Gadjah Mada University
• Investigators: Principal Investigator: Antonia Saktiawati, MD, PhD, Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: screening; tuberculosis; gender; breath test; electronic-nose; remote area
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 002/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No