A5302: BioBank for Surrogate Marker Research for TB (B-SMART)
- To obtain sputum, serum, urine, and peripheral blood mononuclear cells (PBMCs) for central TB biorepository storage from eligible participants undergoing treatment for culture-confirmed pulmonary TB.
- To evaluate the ability of the LitmusB (Vivione Biosciences), a novel flow cytometry assay that detects MTB in sputum, to differentiate viable from non-viable bacilli during the first 8 weeks of TB treatment.
- To evaluate the host proteomic fingerprint in serum of persons with active TB, as defined by Next Generation Proteomics Liquid Chromatography-Mass Spectrometry (LC-MS) analysis and confirmed through multiplexed, high-throughput validated platforms (ie, bead-based immunoassays, aptamer arrays and electrochemiluminescence assays) as well as detection of MTB macromolecules carried on human “exosomes” - small, membrane-bound vesicles emitted from MTB-infected host cells found in the circulating blood of TB-infected participants.
- To evaluate a host metabolomic fingerprint in urine from persons with active TB, identified by LC-MS in serial urine samples obtained during the first 8 weeks of TB treatment.
- To identify and characterize host MTB-specific CD4+ and CD8+ T cell responses, as measured by interferon (IFN)-g ELISPOT(enzyme-linked immunosorbent spot),, using optimized antigens (peptide pools) in the intracellular cytokine staining (ICS) assay with improved sensitivity for detection of MTB, that are predictive of TB treatment failure.
- To collect PBMCs via BD CPT tubes; host peripheral mRNA via the PAXgene system; stimulated supernatant via the Quantiferon-Gold Intube system; and host DNA at select ACTG and TBTC sites that have the capacity and expertise to collect, process, and store such biospecimens for use in future TB biomarker research.