Performance Evaluation of the VIDAS TB-IGRA Assay.
Completed · NCT04048018
Conditions: Active Tuberculosis, Latent Tuberculosis Infection, Non-Tuberculous Mycobacterial (NTM) Pneumonia
At a glance
- Research payments reported, 2025
- $1.0M
- U.S. investigators named
- 6
- Sites paid
- 6
- Planned or actual enrollment
- 2,401
About the trial
- Sponsor
- BioMérieux
- Tested
- Blood draw and IGRA test (diagnostic_test)
- Dates
- Started 2019-12-05; completion 2021-06-30
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2021-07-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Biomerieux Inc reported $1.0M in research payments for this study in 2025 (49 payments).
Products named: Vidas 3, Vidas
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Jeannette L. Aldous, MD Internal Medicine · Encinitas, CA
- David T. Pride, MD, PHD Infectious Disease · San Diego, CA
- Daniel F. Hoft, MD Infectious Disease · St Louis, MO
- Dennis N. Morrison, DO Family Medicine · Springfield, MO
- Kevin L. Winthrop, MD Infectious Disease · Portland, OR
- Jose A. Cadena-zuluaga, MD Infectious Disease · San Antonio, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- San Ysidro Health $287,045
- Saint Louis University $277,302
- Regents of the University of California at San Diego $238,917
- Ohsu Hospital and Clinics, OR $170,520
- The University of Texas Health Science Center at San Antonio $22,811
- Bio Kinetic Clinical Applications, Qps Missouri $14,411
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.