Abstract：
In view of WHO\'s \"End-TB\" strategy, we developed a non-invasive, urine-based ELISA, targeting 2 Mycobacterium tuberculosis antigens namely MPT51 and MPT64 for extrapulmonary TB (EPTB) diagnosis. Suspected EPTB patients (n = 137) [Pleural TB, Abdominal TB and Tuberculous meningitis] were categorized in \"Definite\" EPTB (n = 10) [Xpert-MTB/RIF and/or culture-positive], \"Probable\" EPTB (n = 77) and \"Non-EPTB\" (n = 50) groups using defined composite reference standards. ROC-curves were generated using ELISA results of \"Definite\" EPTB and \"Non-EPTB\" groups for both antigens independently and cut-off values were selected to provide 86.3% (95%CI:73.3-94.2) specificity for MPT51 and 92% (95%CI:80.8-97.8) for MPT64. The sensitivity of MPT51-ELISA and MPT64-ELISA was 70% (95%CI:34.7-93.3) and 90% (95%CI:55.5-99.7) for \"Definite\" EPTB group and 32.5% (95%CI:22.2-44.1) and 30.8% (95%CI:20.8-42.2) for \"Probable\" EPTB group, respectively. Combining the results of both ELISAs showed a 100% (95%CI:69.1-100) sensitivity in \"Definite\" EPTB group and 41.6% (95%CI:30.4-53.4) in \"Probable\" EPTB group, with an 80% (95%CI:66.3-89.9) specificity. The results demonstrated the potential of urine-based ELISAs as screening tests for EPTB diagnosis.
摘要：
鉴于世卫组织的“终结结核病”战略，我们开发了一种非侵入性的，基于尿液的ELISA，针对2种结核分枝杆菌抗原，即MPT51和MPT64，用于肺外结核病（EPTB）诊断。疑似EPTB患者（n=137）[胸膜结核，腹部结核和结核性脑膜炎]分类为“确定”EPTB（n=10）[Xpert-MTB/RIF和/或培养阳性]，使用定义的复合参考标准的\"可能的\"EPTB\"(n=77)和\"非EPTB\"(n=50)组。使用“确定”EPTB和“非EPTB”组的ELISA结果分别对两种抗原产生ROC曲线，并选择临界值以提供对MPT51的86.3％（95CI：73.3-94.2）特异性和MPT64的92％（95CI：80.8-97.8）特异性。MPT51-ELISA和MPT64-ELISA的敏感性为“确定”EPTB组的70％（95CI：34.7-93.3）和90％（95CI：55.5-99.7），而“可能”EPTB组的32.5％（95CI：22.2-44.1）和30.8％（95CI：20.8-42.2），分别。结合两个ELISA的结果显示，“确定”EPTB组中的灵敏度为100％（95CI：69.1-100），“可能”EPTB组中的灵敏度为41.6％（95CI：30.4-53.4），具有80%(95CI:66.3-89.9)的特异性。结果证明了基于尿液的ELISA作为EPTB诊断的筛查测试的潜力。
