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

Not yet recruiting

• Conditions: Tuberculosis; Diagnoses Disease
• Interventions: Device: STANDARDTM F TB LAM FIA

• Registration Number: NCT06306430
• Lead Sponsor: Ospedale San Raffaele

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 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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Status Verified: 2024-05
• Study Start: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
extraPTB	STANDARDTM F TB LAM FIA	Subjects with extrapulmonary TB
HC	STANDARDTM F TB LAM FIA	Healthy controls donors
PTB	STANDARDTM F TB LAM FIA	Subjects with a pulmonary TB
PNTM	STANDARDTM F TB LAM FIA	Subjects with pulmonary NTM

Primary Outcome Measures

Name	Time	Method
Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay	12 months	STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay for the qualitative detection of specific antigen from mycobacterial lipoarabinomannan (LAM) in urine. The test should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR that are Europium (Eu) based fluorescent immunoassay system and have been designed for easy and reliable measuring of diverse parameters.; The test result of a specimen is given either as Positive or Negative with a COI (cut off index) value.; The test may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier-collect biological samples.; The results of the test will be compared to the results of the test performed to confirm the pulmonary TB, the extrapulmonary TB or the pulmonary NTM diagnosis 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.

Secondary Outcome Measures

Name	Time	Method
Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects)	6 months	The test will be repeated at the end of the anti-TB therapy to evaluate if the test can be used as marker of treatment response.We want to evaluate whether, in the face of therapeutic success, the test becomes negative (reversion of results).

Trial Locations

Locations (1)

Emerging Bacterial Pathogens Unit; 🇮🇹 Milan, Italy