Hamasur Beston, Bruchfeld Judith, van Helden Paul, Källenius Gunilla, Svenson Stefan
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.
PLoS One. 2015 Apr 23;10(4):e0123457. doi: 10.1371/journal.pone.0123457. eCollection 2015.
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.
我们之前开发了一种基于检测尿液中分枝杆菌脂阿拉伯甘露聚糖（LAM）的结核病诊断测试。该方法依赖于一个费力的浓缩步骤。我们现在已经开发出一种基于磁免疫分析平台的易于操作的测试方法，利用高亲和力单克隆抗体来检测尿液中的LAM。使用这种方法，该检测的分析灵敏度比传统酶联免疫吸附测定（ELISA）提高了50至100倍。在一项针对微生物学确诊的结核病HIV阴性患者（n = 17）和健康对照者（n = 22）的初步研究中，该测试的灵敏度为82%，特异性为100%。这与一系列使用市售多克隆抗LAM抗体测试的研究形成了鲜明的积极对比，在这些研究中，HIV阴性结核病患者的测试灵敏度非常低。
