A Rapid Blood Test to Differentiate Latent Tuberculosis from Active Disease
Abstract
The purpose of the study is to develop a blood-based TB test that meets or exceeds WHO Target Product Profiles for a rapid, biomarker-based, non-sputum triage test for detecting active TB disease. To accomplish this, activities in Year 1included improvements to the 3-gene mRNA signature and analysis of these improvements; development of a novel 9-genesignature; prototype cartridge development; recruitment and blood collection in Moldova; and development of a secure data transmission system. In Year 2, Aim 2 recruitment and blood collection/processing was completed in Moldova, Cepheid worked to develop two "open" prototype cartridges the Stanford 3-gene signature cartridge for non-stimulated blood, and a prototype antigen-stimulated cartridge. In Year 3, Cepheid completed biostatistics work necessary to validate the signatures and completed internal quality testing toward finalizing the prototype cartridges for field evaluation. The new field site in Pakistan was established, and during the No Cost Extension (NCE) period prospective enrollment began for 3-gene and antigen-stimulated cartridge field testing. Completion of enrollment and data analysis will take place during the addition alone-year NCE period.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1195668
Entities
People
- Antonino Catanzaro
- Laura Myhovich
- Naomi Hillery
- Timothy Rodwell
Organizations
- University of California, San Diego