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.
Highlights
WHO reports that, if left untreated, each person with active tuberculosis (TB) infects between 10 to 15 new individuals annually
In low income countries the most commonly used diagnostic test still is direct sputum smear microscopy, a technique that was developed in the 1880s and since remains largely unchanged. It only detects about half of pulmonary TB patients and is ineffective for diagnosis of TB in young children, in patients co-infected with HIV, and in patients with extra-pulmonary TB
The ELISA titration curve of the same two monoclonal Abs (mAbs) when compared to the reference anti-LAM mAbs Colorado State University (CSU)-35 and CSU40 showed 3 logs higher binding capacity (Fig 2)
Summary
WHO reports that, if left untreated, each person with active tuberculosis (TB) infects between 10 to 15 new individuals annually. In low income countries the most commonly used diagnostic test still is direct sputum smear microscopy, a technique that was developed in the 1880s and since remains largely unchanged. It only detects about half of pulmonary TB patients and is ineffective for diagnosis of TB in young children, in patients co-infected with HIV, and in patients with extra-pulmonary TB. It is often described as a simple technology, microscopy requires a high level of training and diligence and is labor intensive
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