Evaluation of the performance of a new test for the diagnosis of active tuberculosis.
- Conditions
- Health Condition 1: A15-A19- Tuberculosis
- Registration Number
- CTRI/2020/06/026022
- Lead Sponsor
- BIOMERIEUX SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
A person who meets at least one of the criteria below, classifying him/her as suspected of having M. tuberculosis disease (active TB):
- AFB-positive smear microscopy
- Positive nucleic acid amplification test (NAAT) for M. tuberculosis
- Clinical signs/symptoms
- Clinical imagery such as chest X-ray or CT scan compatible with active TB
1. A person who has been on an anti-TB treatment for more than 15 days for the ongoing infection (for MDR-TB, this refers to the second-line treatment)
2. Pregnant women (self-reported)
3. A person who has received an anti-TNF treatment within the previous 3 months
4. A person who has had a TST in the previous 12 weeks
5. A person who has been diagnosed with a NTM infection
6. A person with positive HIV status, confirmed by a laboratory test or via a rapid test performed at time of inclusion or within one month prior to inclusion into this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and positive percent agreement for the VIDAS TB IGRA assay. <br/ ><br> <br/ ><br>Timepoint: After 5 month of recruitment. <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable