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Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis
Sponsor: Ospedale San Raffaele
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).
Official title: Detection of Lipoarabinomannan in Urine, Evaluation of the STANDARDTM F TB LAM FIA and Its Impact on the Initial Diagnosis of TB
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
550
Start Date
2024-10
Completion Date
2025-10
Last Updated
2024-09-26
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Emerging Bacterial Pathogens Unit
Milan, Italy