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 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 -- and Stanford began discovery analysis toward a sub-9-gene signature using a machine learning framework. In Year 3, Cepheid will further develop the"open" prototype cartridges, complete biostatistics work necessary to lock the signatures, and assess and validate their performance; the result will be a final closed prototype cartridge which will be deployed in the field.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2020
- Accession Number
- AD1123382
Entities
People
- Antonino Catanzaro
- Laura Myhovich
- Naomi Hillery
- Timothy Rodwell
Organizations
- University of California, San Diego