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Prospective multicentre head-to-head validation of host blood transcriptomic biomarkers for pulmonary tuberculosis by real-time PCR: Public, subject-level signature scores, RT-qPCR data, and metadata

posted on 04.10.2021, 10:50 by Simon MendelsohnSimon Mendelsohn, Stanley KimbungStanley Kimbung, Andrew Fiore-GartlandAndrew Fiore-Gartland, Adam Penn-Nicholson, Munyaradzi MusvosviMunyaradzi Musvosvi, Humphrey MulengaHumphrey Mulenga, Michelle Fisher, Kate Hadley, Mzwandile Erasmus, Onke Nombida, Michèle Tameris, Gerhard Walzl, Kogieleum Naidoo, Gavin Churchyard, Mark Hatherill, Thomas ScribaThomas Scriba

The Correlate of Risk Targeted Intervention Study (CORTIS-01; ClinicalTrials.gov: NCT02735590), and companion study Validation of Correlates of Risk of TB Disease in High Risk Populations (CORTIS-HR), were conducted to prospectively test the diagnostic and prognostic performance of the RISK11 biomarker for tuberculosis (TB) disease in people without HIV and people living with HIV, respectively, in an ambulant community setting. In addition, CORTIS-01 tested the efficacy of biomarker-guided TB preventive therapy.

The Cross-Sectional TB Cohort (CTBC) study was previously used to validate the diagnostic performance of the RISK11 and RISK6 biomarkers in a case-control study.

The Respiratory Pathogens sub-study evaluated the effect of respiratory viral and bacterial pathogens detected by RT-qPCR on nasopharyngeal and oropharyngeal swabs on RISK11 biomarker scores in people without HIV consecutively recruited in the CORTIS-01 study.

Here we provide the public, subject-level datasets containing key variables necessary to reconstruct the study findings for the Cross-Sectional TB Cohort (CTBC) study, and the CORTIS-01, CORTIS-HR, and Respiratory Pathogens sub-studies evaluating the diagnostic and prognostic performance of multiple parsimonious transcriptomic signatures. Data dictionaries are provided below.

The public datasets for each study are divided into (1) subject-level signature scores and metadata with key variables, and (2) subject-level TaqMan RT-qPCR primer-probe assay raw cycle threshold (CT) gene expression data from the Fluidigm microfluidic gene expression integrated fluidic circuits.


To contribute to control of the global Tuberculosis (TB) epidemic by designing a clinical trial to test a Correlates of Risk-targeted screen-and-treat strategy, which will identify people at highest risk of developing TB disease and treat them, before they become ill and transmit TB to others

Bill & Melinda Gates Foundation

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To contribute to control of the global TB epidemic by testing a strategy to identify undiagnosed TB and those at high risk of developing TB disease using Correlates of Risk so they may be treated before transmitting the disease to others

Bill & Melinda Gates Foundation

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To evaluate a new strategy using the Correlates of Risk signature to determine whether it can be used within a high risk population to detect undiagnosed TB and those at high risk of developing TB disease

Bill & Melinda Gates Foundation

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Respiratory infection assays were funded by the NIH (AI123780)

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

Bill & Melinda Gates Foundation (OPP1116632, OPP1137034, OPP1151915)



Department of Pathology