Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04048018 · ClinicalTrials.gov registry record
Performance Evaluation of the VIDAS TB-IGRA Assay.
A clinical trial, sponsored by BioMérieux.
- Completed
- Registry status
- 2,401
- Enrollment target
NCT04048018: Completed study, sponsored by BioMérieux.
NCT04048018 is a clinical trial that has completed, run by BioMérieux. The registered enrollment target is 2,401 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04048018 has completed, sponsored by BioMérieux.
- COMPLETED
- Registry status
- 2,401 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Blood draw and IGRA test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,401 participants |
| Start Date | 2019-12-05 |
| Est. Completion | 2021-06-30 |
What the finished NCT04048018 record still lists
NCT04048018 is an observational study that tracks outcomes without assigning an intervention. Its 2,401 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Blood draw and IGRA test is the first listed.
NCT04048018 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04048018 about?
NCT04048018 is a clinical study titled "Performance Evaluation of the VIDAS TB-IGRA Assay.". 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 diag...
What is the current status of trial NCT04048018?
This trial is currently completed. The enrollment target is 2,401 participants. The study started on 2019-12-05. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT04048018?
The interventions under investigation include: Blood draw and IGRA test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04048018?
This trial is sponsored by BioMérieux, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05185440 · 2,400 participants · NA
Reducing Alcohol Involved Sexual Violence in Higher Education
- NCT05285527 · 2,400 participants · NA
MiSight 1 Day Safety Post-Approval Study
- NCT05738330 · 2,400 participants · NA
Symptom Monitoring in Hemodialysis
- NCT05833360 · 2,400 participants
Prospective Study of oncRNA Stratification of Cancer by Size and Stage
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI