Performance Evaluation of the VIDAS TB-IGRA Assay.

Completed

Conditions studied: Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia

In brief

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.

Key facts

Study ID

NCT04048018

Run by

BioMérieux

People needed

2401

Starts

2019-12-05

Expected to finish

2021-06-30

Last updated by the study team

2021-07-16

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A person classified as or suspected of having M. tuberculosis disease (active TB):
• A person with known HIV status, determined by a laboratory or rapid test performed no earlier than one month prior to, or at the time of inclusion into this study A person of age ≥ 2 years

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
• Inclusion criteria :
• 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
• Non-inclusion criteria will be:
• 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
• Inclusion criteria
• 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
• Non-inclusion criteria A person who is considered at high risk for LTBI 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-TNFalpha treatment A person who has had a TST Pregnant women A person who has been diagnosed with a NTM infection
• NTM population:
• Inclusion criteria A person who is positive for NTM of interest confirmed by culture and identification;
• Non-inclusion criteria A person who has been on antibiotic treatment for NTM; A person with confirmed active TB; A person with HIV; A person with a history of active TB; A person who have received treatment for LTBI; A person who is at high risk for LTBI Pregnant women.
• Precision Population
• Inclusion criteria:
• A person previously enrolled in the Active TB, High Risk or Low Risk studies, or a blood donor.
• Non-inclusion criteria An adult who was not previously enrolled in the Active TB, High Risk or Low Risk studies except for blood donors
• 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

Where it is running

• Stanford University — Palo Alto, California, United States
• UC San Diego — San Diego, California, United States
• Naional Jewish Health — Denver, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of Illinois- Chicago — Chicago, Illinois, United States
• Saint Louis University — St Louis, Missouri, United States
• Rutgers University — Newark, New Jersey, United States
• Universidade Federal de Mato Grosso do Sul (UFMS) — Campo Grande, Brazil
• Universidade Federal Da Grande Dourados (UFGD) — Dourados, Brazil
• Anti-TB center of Chambéry — Chambéry, France
• Lapeyronie Hospital — Montpellier, France
• Anti-TB center of Nanterre — Nanterre, France
• Avicenne Hospital — Paris, France
• Lariboisière Hospital — Paris, France
• North Hospital — Saint-Etienne, France
• National Center for Tuberculosis and Lung Disease — Tbilisi, Georgia
• Hinduja Hospital — Mumbai, India
• INMI L. Spallanzani — Rome, Italy
• Autonomous University of Baja California — Mexicali, Mexico
• TASK Applied Science, Delft Day Hospital Premises — Cape Town, South Africa
• University of Cape Town Centre for Lung Infection and Immunity — South Africa, South Africa
• Evelina London Children's Hospital — London, United Kingdom
• Royal Free Hospital — London, United Kingdom
• St Thomas' Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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