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

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.