A Rapid Blood Test to Differentiate Latent Tuberculosis from Active Disease
Abstract
This study aimed to develop a blood-based diagnostic test for tuberculosis (TB) that meets or surpasses WHO Target Product Profiles for a rapid, biomarker-based, non-sputum triage test for active TB. Key activities included optimizing an existing 3-gene mRNA signature predictive of active TB disease, developing a novel 9-gene signature and TB antigen stimulated mRNA signature for improved performance and creating prototype diagnostic cartridges for these assays suitable for deployment in existing Cepheid Xpert platforms. We established clinical sites in Moldova for prospective collection of clinical blood samples for assay development and analytical laboratory testing (N=825) and in Pakistan for prospective clinical field evaluation of Cepheid prototype cartridges (N=500). Results from the assay field performance evaluations are being prepared for publication.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jan 01, 2024
- Accession Number
- AD1230190
Entities
People
- Antonino Catanzaro
- Laura Myhovich
- Naomi Hillery
- Timothy Rodwell
Organizations
- University of California, San Diego