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

Detection of Lipoarabinomannan in Urine, Evaluation of the STANDARDTM F TB LAM FIA and Its Impact on the Initial Diagnosis of TB

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Tuberculosis; Diagnoses Disease
• Intervention / Treatment: Device: STANDARDTM F TB LAM FIA

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 Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Emerging Bacterial Pathogens Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Subjects attending the Infectious Diseases Ward of the participating centers with a pulmonary TB, pulmonary NTM or extrapulmonary TB. Healthy controls,

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PTB; Subjects with a pulmonary TB	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.
PNTM; Subjects with pulmonary NTM	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.
extraPTB; Subjects with extrapulmonary TB	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.
HC; Healthy controls donors	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects)	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).	6 months

Collaborators and Investigators

• Sponsor: Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Disease; Tuberculosis
• Other Study ID Numbers: uLAM TB FIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No