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

NCT06306430 | Not Yet Recruiting

• 1 other identifier: uLAM TB FIA
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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).

Conditions

Tuberculosis; Diagnoses Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects)

  6 months

Study Arms (4)

PTB

Subjects with a pulmonary TB

Device: STANDARDTM F TB LAM FIA

PNTM

Subjects with pulmonary NTM

Device: STANDARDTM F TB LAM FIA

extraPTB

Subjects with extrapulmonary TB

Device: STANDARDTM F TB LAM FIA

HC

Healthy controls donors

Device: STANDARDTM F TB LAM FIA

Interventions

STANDARDTM F TB LAM FIA DEVICE

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; PNTM; PTB; extraPTB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• Adult subjects with documented active pulmonary TB, pulmonary NTM or extrapulmonary TB
• Subjects who have signed informed consent
• Aged ≥18 years
• healthy donors who have signed informed consent
• aged ≥ 18 years
• no TB or NTM risk factors or exposure

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

Emerging Bacterial Pathogens Unit

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head Emerging Bacterial Pathogens Unit

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 12, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-05

Locations

IT (1)