A sensitive urinary lipoarabinomannan test for tuberculosis

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

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal / immunology
  • Biomarkers / urine*
  • Case-Control Studies
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Lipopolysaccharides / immunology
  • Lipopolysaccharides / urine*
  • Pilot Projects
  • Sensitivity and Specificity
  • Tuberculosis / diagnosis*
  • Tuberculosis / urine

Substances

  • Antibodies, Monoclonal
  • Biomarkers
  • Lipopolysaccharides
  • lipoarabinomannan

Grant support

The study was in the early stage supported by grants from the European Community, the Swedish Medical Research Council, King Oscar II Jubilee Foundation, the Swedish Heart–Lung Foundation and funding from the European Union's Seventh Framework Program (FP7/2007-2013) under grant agreement nº221948, ICONZ (Integrated Control of Neglected Zoonoses). The production of mAbs against LAM was partially funded by Foundation for Innovative New Diagnostics. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.