Evaluation of a lateral flow multi-biomarker diagnostic test for tuberculosis

We performed a prospective cohort study of adults and adolescents presenting with symptoms compatible with TB from South Africa, The Gambia, Uganda and Vietnam. Prior to microbiological confirmation, 20 µL of capillary blood was analyzed using a multi-biomarker test (MBT) with 3 host cytokines. Accuracy of the test was determined in relation to GeneXpert Ultra results and case definition algorithm incorporating clinical and microbiological findings with patients classified as having TB or other respiratory diseases (ORD). Data analysis was performed in R using the Tidymodels machine learning framework.