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Clinical trialNCT04048018CompletedObservational

Performance Evaluation of the VIDAS TB-IGRA Assay.

SponsorBioMérieuxEnrollment2,401Active TuberculosisLatent Tuberculosis InfectionNon-Tuberculous Mycobacterial (NTM) Pneumonia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

24 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil
  • Universidade Federal de Mato Grosso Do Sul (ufms)

    Campo Grande, Brazil

  • Universidade Federal Da Grande Dourados (ufgd)

    Dourados, Brazil

France
  • 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

Georgia
  • National Center for Tuberculosis and Lung Disease

    Tbilisi, Georgia

India
  • Hinduja Hospital

    Mumbai, India

Italy
  • Inmi L. Spallanzani

    Rome, Italy

Mexico
  • Autonomous University of Baja California

    Mexicali, Mexico

South Africa
  • 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

United Kingdom
  • Evelina London Children'S Hospital

    London, United Kingdom

  • Royal Free Hospital

    London, United Kingdom

  • St Thomas' Hospital

    London, United Kingdom

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
5 Dec 2019
Primary completion
30 Jun 2021
Completion
30 Jun 2021
Last update posted
16 Jul 2021
Registered enrollment
2,401
Registry id
NCT04048018
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.