NCT03025516

Performance Evaluation of TB Breath- and Cough-testing Platforms

Performance Evaluation of Two Diagnostic Technologies for TB Detection Based Upon Breath Testing

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 360 (estimated)
• Sponsor: Find · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy of two TB breath-based technologies independently of the manufacturers. Assay error and failure rates and device operational characteristics will also be assessed during this study. Participants will be enrolled in this study in line with FIND sample banking activities. Results from index tests will not be used to make clinical decisions. Participation in this study will not alter the standard of care.

Conditions

• Pulmonary TB
• Diagnoses Diseases

Interventions

Type	Name	Description
DEVICE	Rapid Biosensor Systems (RBS) TB Breathalyser	Rapid Biosensor Systems (RBS) recently developed a portable, non-invasive, rapid TB diagnostic 'Breathalyser' capable of diagnosing TB in patient breath samples collected while patients cough (Figure 1). The TB Breathalyser comprises a disposable, single-use sample collection tube and a multi-use reader. At the bottom of the collection tube is a glass bio-sensor coated with a biochemical sensor that is formulated to react with TB bacilli. Patients cough into the collection tube after nebulization with 0.9% saline solution. Following sample collection, the tube is placed into the reader, where a diode laser interrogates the biochemical coating in the sample collection tube and reports the presence of TB bacilli. The entire process takes about two minutes.
DEVICE	eNose AeonoseTM	The eNose Company has also developed a hand-held, non-invasive rapid TB diagnostic 'electronic nose' (AeonoseTM) for TB detection based upon analysis of exhaled breath. After the device has been calibrated, the patient is instructed to breathe into the device through a mouthpiece for 5 minutes. Within the device is a micro-hotplate, metal-oxide sensor which behaves as a semiconductor at high temperature. Redox-reactions occurring at the sensor surface result in changes in resistance, with results read and interpreted by a phone application to confirm the presence of MTB.

Timeline

• Start date: 2017-05-29
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2017-01-19
• Last updated: 2017-07-21

Locations

1 site across 1 country: South Africa