Performance Evaluation of the VIDAS TB-IGRA Assay. (NCT04048018) | Clinical Trial Compass
CompletedNot Applicable
Performance Evaluation of the VIDAS TB-IGRA Assay.
United States, Brazil, France2,401 participantsStarted 2019-12-05
Plain-language 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.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Active TB Population
Inclusion Criteria:
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
Exclusion Criteria:
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Positive, negative, indeterminate for tuberculosis
Timeframe: One-time measurement through study completion for each participant, an average of 5 months.
2
Sensitivity and positive and negative percent agreement for the VIDAS TB IGRA assay with comparator assay
Timeframe: One-time measurement through study completion for each participant, an average of 5 months.
3
Degree of Interference by nontuberculous mycobacteria for the VIDAS TB IGRA assay
Timeframe: One-time measurement through study completion for each participant, an average of 5 months.
4
Measurement Precision of the VIDAS TB IGRA assay results
Timeframe: Triplicate measurement per sample through study completion, an average of 5 months.