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

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Tuberculosis; Diagnoses Disease

Treatments: Device: STANDARDTM F TB LAM FIA

Study type: Observational

Funder types: Other

Identifiers

NCT06306430

uLAM TB FIA

Details and patient eligibility

About

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).

Full 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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria for PTB, PNTM and extraPTB:

• Adult subjects with documented active pulmonary TB, pulmonary NTM or extrapulmonary TB
• Subjects who have signed informed consent
• Aged ≥18 years

Inclusion criteria for HC:

• healthy donors who have signed informed consent
• aged ≥ 18 years
• no TB or NTM risk factors or exposure

Exclusion criteria

Exclusion criteria for PTB, PNTM and extraPTB:

• Do not have active pulmonary TB, NTM or extrapulmonary TB
• Do not sign the informed consent
• Are aged < 18 years

Exclusion criteria for HC:

• Have active pulmonary TB or NTM
• Do not sign the informed consent
• Are aged < 18 years

Trial design

550 participants in 4 patient groups

PTB

Description:

Subjects with a pulmonary TB

Treatment:

Device: STANDARDTM F TB LAM FIA

PNTM

Description:

Subjects with pulmonary NTM

Treatment:

Device: STANDARDTM F TB LAM FIA

extraPTB

Description:

Subjects with extrapulmonary TB

Treatment:

Device: STANDARDTM F TB LAM FIA

HC

Description:

Healthy controls donors

Treatment:

Device: STANDARDTM F TB LAM FIA