Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306430
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-02-21
Brief Title:
Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis
Sponsor:
Ospedale San Raffaele
Organization:
Ospedale San Raffaele
Study Overview
Official Title:
Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTM F TB LAM FIA and Its Impact on the Initial Diagnosis of TB
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
uLAMTBFIA
Brief Summary:
Evaluation of the performance of an in vitro test the STANDARDTM F TB LAM Ag FIA SD BIOSENSOR INC for the early diagnosis of tuberculosis TB infection This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection The test will be used according to the instructions for use IFU
Detailed Description:
STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay which detects lipoarabinomannan in human urine sample The test evaluated in this study may provide benefits for the development of non sputum-based less invasive tuberculosis diagnostics that include easier to collect biological samples The study can therefore be relevant for updating WHO guidelines for TB diagnosis The results of the STANDARDTM F TB LAM Ag FIA will be interpreted according to the manufacturers instructions and will be compared to the results of the test performed to confirm the pulmonary TB the extrapulmonary TB or the pulmonary NTM diagnosis intention to treat assay The test will be repeted at the end of the anti-TB therapy to evaluate if the test can be used as marker of treatment response Healthy subjects without exposure or risk for TB factors will serve as a proxy for specificity subjects with confirmed TB will serve as control group to estimate sensitivity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None