Therefore, effective control of TB requires disruption of transmission chains, which in turn requires early and accurate detection/diagnosis paired with appropriate treatment. WHO reports that, if left untreated, each person with active tuberculosis (TB) infects between 10 to 15 new individuals annually. The remaining authors have declared that no competing interests exist. This does not alter the authors' adherence to all the PLoS ONE policies on sharing data and material. SS was cofounder of TBDiadirect and also inventor together with Beston Hamasur. BH is one of the inventors of a Swedish patent application (1450908-7) filed on these findings, which is owned by TBDiadirect AB. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.Ĭompeting interests: BH and GK are co-founders of TBDiadirect AB, a start-up company aiming at developing the Uri-TB-direct test.
The production of mAbs against LAM was partially funded by Foundation for Innovative New Diagnostics. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are creditedĭata Availability: All relevant data are within the paper.įunding: 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 n✢21948, ICONZ (Integrated Control of Neglected Zoonoses). Received: DecemAccepted: MaPublished: April 23, 2015Ĭopyright: © 2015 Hamasur et al. PLoS ONE 10(4):Īcademic Editor: Jérôme Nigou, Centre National de la Recherche Scientifique - Université de Toulouse, FRANCE The question whether the assay is suitable as a supplemental device in the diagnosis of HIV-associated TB, requires further investigations.Citation: Hamasur B, Bruchfeld J, van Helden P, Källenius G, Svenson S (2015) A Sensitive Urinary Lipoarabinomannan Test for Tuberculosis. Conclusion: This commercially available generation of LAM-ELISA does not appear to be useful as an independent diagnostic test for pulmonary tuberculosis. Correlation with urinalysis revealed that proteinuria was significantly and positively associated with LAM-positivity (P = 0.026). The specificity amounted to 87.8% and was determined in participants with negative results in all microbiological tests and with sustained recovery under antibiotic treatment at day 56. The sensitivity was noticeably higher in females (66.7%) and in HIV positive participants (62.0%). Results: Only 35 out of 69 pulmonary TB cases-confirmed by smear microscopy and/or solid culture and/or liquid culture-showed at least one positive LAM-ELISA result (sensitivity 50.7%). The participants were subsequently assigned to classification groups according to microbiological, clinical and radiological findings at recruitment and during a maximum follow up period of 56 days. Methods: The test was applied to two urine samples from 291 consecutively enrolled Tanzanian patients with suspected pulmonary tuberculosis. In the present study, the now commercially available assay has been clinically assessed regarding its diagnostic value alone and in combination with clinical co-factors. In a previous study, the first release of a urine LAM-ELISA by Chemogen (Portland, USA) has been evaluated with a promising sensitivity and specificity for the diagnosis of pulmonary TB. Background: The development and evaluation of rapid and accurate new diagnostic tools is essential to improve tuberculosis (TB) control in developing countries.
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