Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-27 @ 8:05 PM
Study NCT ID:
NCT02912832
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Assessment of TBDx Feasibility
Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Organization:
Study Overview
Official Title:
TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: