Tuberculosis Biomarkers and Uses Thereof

Abstract

The present application includes biomarkers, methods, devices, reagents, systems, and kits for the detection, treatment and diagnosis of tuberculosis (TB). In one aspect, the present application includes the identification of biomarkers that can be used alone or in various combinations for the detection of TB, including those set forth in Tables 1, 2, 4, 5, and 8 to 12. In another aspect, the application provides biomarkers that can be used alone or in various combinations to diagnose or prognose TB or follow treatment response. In another aspect, methods are provided for diagnosing TB in an individual, where the methods include detecting, in a biological sample from an individual, at least one biomarker value corresponding to at least one biomarker selected from the group of biomarkers provided in Tables 1, 2, 4, 5, and 8 to 12, wherein the individual is classified as having TB, or the likelihood of the individual having TB is determined, based on the at least one biomarker value.

1 . A method comprising detecting the level of at least one biomarker selected from the group consisting of PSME1, HSP 70, α2-antiplasmin, IFN-λ, MMP-12, IL-11 Ra, Galectin-8, MMP-13, iC3b and APRIL in a sample from an individual;
 predicting whether the individual has an increased likelihood of being culture negative for TB after a treatment for TB, wherein the predicting is based on a classification method that uses the level of the at least one biomarker as input for the classification method; 
 wherein the classification method was developed by comparing samples from at least a first reference group and a second reference group, wherein the first reference group was culture negative for TB after treatment for TB, and the second reference group was culture positive for TB after treatment for TB; 
 wherein the level of each biomarker protein is detected with a capture reagent-based assay, and wherein the capture reagents is selected from the group consisting of an aptamer and an antibody; and 
 wherein, the individual is infected with TB.