A novel method for detecting Lipoarabinomannan in urine with the promise of meeting the WHO target product profile for the diagnosis of tuberculosis

The diagnosis of tuberculosis largely relies on the detection of Mycobacterium tuberculosis (M. tuberculosis) via pathogen-specific DNA or bacterial culture from sputum samples. As the only point-of-care test so far, urinary lipoarabinomannan (LAM) has been endorsed by the World Health Organization for the diagnosis of tuberculosis in people living with HIV. In this study, the electrochemiluminescence LAM research assay (EclLAM) was used to measure LAM in the urine of HIV-sero-negative individuals with pulmonary tuberculosis and to monitor anti-tuberculosis treatment. Urine samples from 18 patients with microbiologically confirmed tuberculosis were analyzed before and after the initiation of anti-tuberculosis therapy and 17 healthy controls via the S4-20/A194-01 antibody pair. The assay identified 13/18 (72.2 %) patients with tuberculosis and was negative in 17/17 (100.0 %) controls (AUC 0.88). The results of the reactive urine LAM tests correlated with the detection of M. tuberculosis growth in culture (r = 0.94, p < 0.05). In conclusion, the LAM-specific antibody assay is promising to fulfill the WHO target product profile for the diagnosis of tuberculosis. • High sensitivity and specificity reached measuring LAM in urine of TB patients. • Diagnosis of TB+/HIV- patients with a sensitivity of 72.2 % and 100 % specificity. • LAM concentrations in urine correlate with the Mtb growth in culture during therapy. • EclLAM assay S4-20/A194-01 is promising to fulfil the WHO target product profile.