Performance Evaluation of the VIDAS TB-IGRA Assay.

NCT04048018 | Completed FDA Device

• 1 other identifier: B2694-CTPR
• Study Type: observational
• Target: 2,401
• Locations: 9 countries
• Sites: 24

Brief Summary

This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection. This study is designed to assess (1) the sensitivity of this assay, (2) its percent agreement with other diagnostic tests, (3) its measurement precision , and (4) any potential interference of the presence of other non-tuberculosis mycobacterial bacterial infections with this assay.

Conditions

Active Tuberculosis; Latent Tuberculosis Infection; Non-Tuberculous Mycobacterial (NTM) Pneumonia

Keywords

Interferon Gamma Release Assay; Tuberculosis

Outcome Measures

Primary Outcomes (4)

• Positive, negative, indeterminate for tuberculosis

  The VIDAS or comparator assays will qualitatively determine the presence or absence of Mycobacterial TB infection in a participant's blood. This measurement is based on the level of interferon gamma released after stimulation of T cells in blood.

  One-time measurement through study completion for each participant, an average of 5 months.

• Sensitivity and positive and negative percent agreement for the VIDAS TB IGRA assay with comparator assay

  Results obtained using the VIDAS assay will be compared with the results obtained from other methods.

  One-time measurement through study completion for each participant, an average of 5 months.

• Degree of Interference by nontuberculous mycobacteria for the VIDAS TB IGRA assay

  Persons with NTM will be tested using the VIDAS TB IGRA.

  One-time measurement through study completion for each participant, an average of 5 months.

• Measurement Precision of the VIDAS TB IGRA assay results

  6- 4mL blood samples will be collected from each participant and tested using different VIDAS instruments.

  Triplicate measurement per sample through study completion, an average of 5 months.

Study Arms (5)

Active Tuberculosis Patient

Diagnostic Test: Blood draw and IGRA test

High risk for LTBI Participant

Diagnostic Test: Blood draw and IGRA test

Low risk for prior TB infection Participant

Diagnostic Test: Blood draw and IGRA test

NTM patient

Diagnostic Test: Blood draw and IGRA test

Precision patient

Diagnostic Test: Blood draw and IGRA test

Interventions

Blood draw and IGRA test DIAGNOSTIC_TEST

One to two blood samples will be obtained from participants in all arms in order to conduct testing.

Active Tuberculosis Patient; High risk for LTBI Participant; Low risk for prior TB infection Participant; NTM patient; Precision patient

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll persons with low to high risk factors for acquiring TB infection, persons with active TB disease, and persons with other types of Mycobacterial infections

You may qualify if:

• A person classified as or suspected of having M. tuberculosis disease (active TB):

You may not qualify if:

• A person who has been on an anti-TB treatment for \>15 days for the ongoing infection Pregnant women A person who has received an anti-tumor necrosis factor (TNF) alpha treatment within the previous 3 months A person who has had prior TST A person with an NTM infection A person with positive HIV status.
• High Risk for TB infection
• A person who is at increased risk for M. tuberculosis infection (and therefore LTBI) and/or for progression to active TB:
• A person with age ≥ 2 years A person with known HIV status
• A person who has or has had active TB A person who has received treatment for active TB or LTBI A person who has received an anti-TNF alpha treatment A person who has had a TST Pregnant women Person who has been an NTM infection
• Low Risk for TB Infection
• Generally healthy people, unlikely to have encountered TB disease in the past, that may be subject to TB testing for professional, academic or personal reasons (e.g.: students, healthcare personnel and healthcare volunteers, military recruits) A person with age ≥ 18 years old
• NTM population:
• Precision Population
• A person previously enrolled in the Active TB, High Risk or Low Risk studies, or a blood donor.
• For blood donors only:
• A person who can be classified as being at increased risk for M. tuberculosis infection (and therefore LTBI) and/or for progression to active TB

Sponsors & Collaborators

• BioMérieux: lead

Study Sites (24)

Stanford University

Palo Alto, California, 94304, United States

Location

UC San Diego

San Diego, California, 92103, United States

Location

Naional Jewish Health

Denver, Colorado, 80206, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Illinois- Chicago

Chicago, Illinois, 60612, United States

Location

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Rutgers University

Newark, New Jersey, 07103, United States

Location

Universidade Federal de Mato Grosso do Sul (UFMS)

Campo Grande, Brazil

Location

Universidade Federal Da Grande Dourados (UFGD)

Dourados, Brazil

Location

Anti-TB center of Chambéry

Chambéry, France

Location

Lapeyronie Hospital

Montpellier, France

Location

Anti-TB center of Nanterre

Nanterre, France

Location

Avicenne Hospital

Paris, France

Location

Lariboisière Hospital

Paris, France

Location

North Hospital

Saint-Etienne, France

Location

National Center for Tuberculosis and Lung Disease

Tbilisi, Georgia

Location

Hinduja Hospital

Mumbai, India

Location

INMI L. Spallanzani

Rome, Italy

Location

Autonomous University of Baja California

Mexicali, Mexico

Location

TASK Applied Science, Delft Day Hospital Premises

Cape Town, South Africa

Location

University of Cape Town Centre for Lung Infection and Immunity

South Africa, South Africa

Location

Evelina London Children's Hospital

London, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

St Thomas' Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Latent Tuberculosis; Pneumonia; Tuberculosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• David Pride

  UC San Diego

  PRINCIPAL INVESTIGATOR

• Maria Gennaro

  Rutgers University

  PRINCIPAL INVESTIGATOR

• Michael Lauzardo

  University of Florida

  PRINCIPAL INVESTIGATOR

• Niaz Banaei

  Stanford University

  PRINCIPAL INVESTIGATOR

• Nahed Ismail

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

• Daniel Hoft

  St. Louis University

  PRINCIPAL INVESTIGATOR

• Charles Daley

  National Jewish Health

  PRINCIPAL INVESTIGATOR

• Amanda Lopes

  Lariboisière Hospital

  PRINCIPAL INVESTIGATOR

• Frederic Méchaï

  Avicenne Hospital

  PRINCIPAL INVESTIGATOR

• Florence Doucet-Populaire

  Antoine-Béclère Hospital

  PRINCIPAL INVESTIGATOR

• Elisabeth Botelho-Nevers

  North Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 7, 2019
• Study Start: December 5, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); GE (1); BR (2); IT (1); FR (6); IN (1); ZA (2); GB (3); ME (1)