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Performance Evaluation of the VIDAS TB-IGRA Assay.

NCT04048018 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2401

Last updated 2021-07-16

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Blood draw and IGRA test

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

Sponsors & Collaborators

  • BioMérieux

    lead INDUSTRY

Principal Investigators

  • David Pride · UC San Diego

  • Maria Gennaro · Rutgers University

  • Michael Lauzardo · University of Florida

  • Niaz Banaei · Stanford University

  • Nahed Ismail · University of Illinois Chicago

  • Daniel Hoft · St. Louis University

  • Charles Daley · National Jewish Health

  • Amanda Lopes · Lariboisière Hospital

  • Frederic Méchaï · Avicenne Hospital

  • Florence Doucet-Populaire · Antoine-Béclère Hospital

  • Elisabeth Botelho-Nevers · North Hospital

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Device
Yes

Countries

  • United States
  • Brazil
  • France
  • Georgia
  • India
  • Italy
  • Mexico
  • South Africa
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04048018 on ClinicalTrials.gov