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Budde, K.* ; Lange, C.* ; Reimann, M.* ; Zielinski, N.* ; Meiwes, L.* ; Köhler, N.* ; DZIF TB cohort study group (Hoelscher, M.)

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

Tuberculosis 152:40048961 (2025)

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	Open Access Gold (Paid Option)

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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.

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Publication type Article: Journal article

Document type Scientific Article

Corresponding Author

Keywords Biomarker ; Diagnostic Tests ; Enzyme-linked Immunosorbent Assay ; Lipoarabinomannan ; Mycobacterium Tuberculosis ; Pulmonary Tuberculosis

ISSN (print) / ISBN 1472-9792

e-ISSN 1873-281X

Journal Tuberculosis

Quellenangaben Volume: 152, Article Number: 40048961

Publisher Elsevier

Non-patent literature Publications

Reviewing status Peer reviewed

Institute(s) Research Unit Global Health (UGH)