Low sensitivity of a urine LAM-ELISA in the diagnosis of pulmonary tuberculosis.
Low sensitivity of a urine LAM-ELISA in the diagnosis of pulmonary tuberculosis.
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DOI：
10.1186/1471-2334-9-141
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发表时间：
2009-08-28
影响因子：
3.7
通讯作者：
Hoelscher M
中科院分区：
文献类型：
--
作者：
Reither K;Saathoff E;Jung J;Minja LT;Kroidl I;Saad E;Huggett JF;Ntinginya EN;Maganga L;Maboko L;Hoelscher M
开发和评估快速、准确的新诊断工具对于改善发展中国家的结核病控制至关重要。在先前的研究中，已经评价了Chemogen（波特兰，美国）首次发布的尿LAM-ELISA对于肺TB诊断具有有希望的灵敏度和特异性。在本研究中，已对目前市售的检测试剂盒单独和与临床辅助因子联合的诊断价值进行了临床评估。该试验应用于291名连续入选的坦桑尼亚疑似肺结核患者的两份尿样。随后根据招募时和最长56天随访期间的微生物学、临床和放射学结果将参与者分配到分类组。在69例肺结核病例中，只有35例经涂片显微镜检查和/或固体培养和/或液体培养证实，显示至少一个阳性LAM-ELISA结果（灵敏度50.7%）。女性（66.7%）和HIV阳性参与者（62.0%）的敏感性明显较高。特异性为87.8%，在所有微生物检测结果为阴性的参与者中确定，并在第56天抗生素治疗下持续恢复。与尿常规相关性分析显示，蛋白尿与LAM阳性显著正相关（P = 0.026）。这种市售的LAM-ELISA一代似乎不能作为肺结核的独立诊断试验。该检测试剂盒是否适合作为诊断HIV相关TB的补充设备，需要进一步研究。
The development and evaluation of rapid and accurate new diagnostic tools is essential to improve tuberculosis (TB) control in developing countries. 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. 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. The test was applied to two urine samples from 291 consecutively enrolled Tanzanian patients with suspected pulmonary tuberculosis. 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. 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 sensitivity was noticeably higher in females (66.7%) and in HIV positive participants (62.0%). 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. Correlation with urinalysis revealed that proteinuria was significantly and positively associated with LAM-positivity (P = 0.026). This commercially available generation of LAM-ELISA does not appear to be useful as an independent diagnostic test for pulmonary tuberculosis. The question whether the assay is suitable as a supplemental device in the diagnosis of HIV-associated TB, requires further investigations.