NCT06306430

Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis

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
• Phase: —
• Study type: Observational
• Enrollment: 550 (estimated)
• Sponsor: Ospedale San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 manufacturer´s 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.

Conditions

• Tuberculosis
• Diagnoses Disease

Interventions

Type	Name	Description
DEVICE	STANDARDTM F TB LAM FIA	STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay for the qualitative detection of specific antigen from mycobacterial lipoarabinomannan (LAM) in urine specimen. STANDARDTM F TB LAM Ag FIA should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR.

Timeline

• Start date: 2024-10-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2024-03-12
• Last updated: 2024-09-26

Locations

1 site across 1 country: Italy