5 files

Validation of Correlates of Risk of TB Disease in High Risk Populations (CORTIS-HR) Study: Public, subject-level RISK11 signature scores and metadata

posted on 29.03.2021, 07:47 by Simon Mendelsohn, Andrew Fiore-Gartland, Adam Penn-Nicholson, Humphrey Mulenga, Stanley Kimbung, Bhavesh Borate, Kate Hadley, Chris Hikuam, Munyaradzi Musvosvi, Nicole Bilek, Mzwandile Erasmus, Lungisa Jaxa, Rodney Raphela, Onke Nombida, Masooda Kaskar, Tom Sumner, Richard White, Craig Innes, William Brumskine, Andriëtte Hiemstra, Stephanus T. Malherbe, Razia Hassan-Moosa, Michèle Tameris, Gerhard Walzl, Kogieleum Naidoo, Gavin Churchyard, Thomas Scriba, Mark Hatherill
The Validation of Correlates of Risk of TB Disease in High Risk Populations (CORTIS-HR) Study, a companion study of the CORTIS-01 Trial (ClinicalTrials.gov: NCT02735590), was conducted to test the diagnostic and prognostic performance of the RISK11 biomarker for tuberculosis (TB) disease in people living with HIV (PLHIV) in an ambulant community setting.

The “CORTIS-HR pubdata.csv” is a public, subject-level dataset for the CORTIS-HR study containing key variables necessary to reconstruct the study findings. A data dictionary is provided below. The “CORTIS-HR PCR data.csv” provides subject-level TaqMan qPCR probe raw CT (cycle threshold) gene expression data from the Fluidigm microfluidic 96.96 Gene Expression Integrated Fluidic Circuits (chips) with sample quality control (“SAMPLE_QC”) results. Analyses of the qPCR probe data are ongoing; the embargo on this data ends 1 July 2021 when the data will be available on ZivaHub. “CORTIS-HR Protocol Version 1.0.pdf” and “CORTIS-HR SAP Version 1.0.pdf” are the protocol and the statistical analysis plan for the study respectively and have been included for reference.


Bill & Melinda Gates Foundation (BMGF) (OPP1151915)

Strategic Health Innovation Partnerships Unit of the South African Medical Research Council with funds received from the South African Department of Science and Technology



Department of Pathology