Performance Evaluation of Abbott TB Rapid Test
Not Applicable
- Conditions
- Health Condition 1: J00-J99- Diseases of the respiratory system
- Registration Number
- CTRI/2024/03/064730
- Lead Sponsor
- Abbott Diagnostics Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
HIV positive status and CD4 count = 200 cells/ mm3
Exclusion Criteria
Individual currently under anti-tuberculosis treatment (ATT)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic performance evaluation of Determine TB LAM Ag TestTimepoint: This is approximately 12 months study for enrolling 330 patients which we expect to start from 1st of April 2024 and complete on or before Mar 2025 and result analysis will be done within Mar/Apr 2025
- Secondary Outcome Measures
Name Time Method A point-of-Care urinary LAM assay, for detection of active TB disease in people living with HIV (PLHIV) with CD4 counts less than or equal to 200 cells/mm in IndiaTimepoint: This is approximately 12 months study for enrolling 330 patients which we expect to start from 1st of April 2024 & complete on or before Mar 2025 & result analysis will be done within Mar/Apr 2025