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。