Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-06-26 @ 4:10 AM
Study NCT ID:
NCT02142894
Status:
COMPLETED
Last Update Posted:
2019-06-18
First Post:
2014-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the QuantiFERON-TB Test.
Sponsor:
QIAGEN Gaithersburg, Inc
Organization:
Study Overview
Official Title:
Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection
Status:
COMPLETED
Status Verified Date:
2019-06
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:
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Detailed Description:
The objective of the study was to enroll patients who have clinical signs/symptoms strongly indicating TB and who are receiving of have to start the treatment for active TB, and test the variants of the CST001 assay to support the evaluation of clinical sensitivity.
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?: