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PLoS One. 2015 Apr 23;10(4):e0123457. doi: 10.1371/journal.pone.0123457. eCollection 2015.

A sensitive urinary lipoarabinomannan test for tuberculosis.

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Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden.
Unit of Infectious Diseases, Institution of Medicine, Karolinska Institutet Solna and, Karolinska University Hospital, Solna, Stockholm, Sweden.
DST/NRF Centre of Excellence for Biomedical TB Research, US/MRC Centre for TB Research, Division of Molecular Biology and Human Genetics, Faculty of Health Sciences, Stellenbosch University, Tygerberg, South Africa.


We have previously developed a diagnostic test for tuberculosis based on detection of mycobacterial lipoarabinomannan (LAM) in urine. The method depended on a laborious concentration step. We have now developed an easy to perform test based on a magnetic immunoassay platform, utilizing high avidity monoclonal antibodies for the detection of LAM in urine. With this method the analytical sensitivity of the assay was increased 50-100-fold compared to conventional ELISA. In a pilot study of HIV-negative patients with microbiologically verified TB (n=17) and healthy controls (n=22) the sensitivity of the test was 82% and the specificity 100%. This is in stark positive contrast to a range of studies using available commercial tests with polyclonal anti-LAM Abs where the sensitivity of the tests in HIV-negative TB patients was very low.

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