Identification of lung macrophage secreted biomarkers for the development of rapid, accurate and affordable point-of-care tuberculosis diagnosis test suitable in low income settings

Tuberculosis (TB) remains a serious public health challenge. The diagnosis of TB is still challenging in resource limited settings where most TB cases are notified. Penn-Nicholson et al followed up a cohort of 8000 healthy latent TB, HIV negative, infected adolescents. Forty-two adolescents developed TB within two years and 300 biomarkers were differentially expressed between TB disease progressors and non-progressors months before onset of TB symptoms. The diagnostic utilities of these biomarkers have not been evaluated. The present study aims to validate the diagnostic utility of promising biomarkers for point-of-care TB testing. We have conducted a prospective study from Jun 2020 to December 2021 recruiting all patients with symptoms suspicious of TB disease and presenting to our laboratory for testing. Basic demographic and health information including sex, age, weight, smoking, diabetes and HIV status were collected from all participants. We will validate the diagnostic utility of up to 100 identified prognostic biomarkers from Penn-Nicholson et al study using ELISA. We have recruited more than 500 participants including 150 confirmed TB cases. We conducted a pilot study evaluating the diagnostic utility of creatine kinase myocardial band (CK-MB), hepcidin (HEPC), phospholipase A2 group IIA (PLa2G2A) and myosin-binding protein C (MYBPC1). CK-MB and HEPC could diagnose TB disease with 78% and 80% accuracy. Evaluation of the remaining biomarkers is still on-going. Results will be presented during the congress.