NCT02912832

Prospective Assessment of TBDx Feasibility

TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 572 (actual)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study will be to determine the performance characteristics of TBDx with culture as a gold standard. In addition, the investigators will assess the laboratory technicians' appraisal and technical suitability of the TBDx system.

Detailed description

This will be a blinded, prospective study to determine the performance of the TBDx system for detection of pulmonary TB in comparison to LED microscopy and culture as a gold standard. The study will involve recruitment of 300 TB suspects per site with a high workload and experienced technicians. Participants will be recruited under the FIND TB Reference Materials project and leftover sputum samples used for the assessment of the TBDx.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DEVICE	TBDx	The TBDx is an automated platform is based on an Olympus BX41 microscope with a 40 x objective lens, fitted with an Olympus XC 10 colour camera and a movable slide stage, with an attached computer that receives high-quality digital images acquired from the camera. The computer then operates detection algorithms that segment, evaluate, and classify objects of interest in these images which can be stored for subsequent review. The platform is able to integrate an optional 200-slide automated slide loader for high volume settings. The application can capture 100, 300 or more digital fields-of-view and can provide results for positive or negative smears in 5 minutes or less.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-03-01
• Completion: 2015-08-01
• First posted: 2016-09-23
• Last updated: 2016-09-23

Locations

2 sites across 2 countries: Peru, Vietnam