Development of a highly-sensitive urine test for tuberculosis (TB) that detects diverse forms of urinary TB lipoarabinomannan (uLAM)

PROJECT ABSTRACT Tuberculosis (TB) remains a major world-wide health problem and the development of a sensitive point-of-care (POC) diagnostic for active TB infection is a global public health priority. Lateral flow (LF) assays based on the detection of mycobacterial lipoarabinomannan (LAM) antigen in patient urines are potential POC tests for TB, but current assays have suboptimal sensitivity, and are not suitable for all populations. An early form of this assay, the Alere Determine™ TB LAM Ag test, was strongly recommended by the WHO for diagnosis of active TB in HIV-positive patients with a CD4 cell count of