Department of Experimental Medicine and Biotechnology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Centre for Biodesign and Diagnostics, Translational Health Science and Technology Institute, NCR Biotech Science Cluster, Faridabad, India.
Diagn Microbiol Infect Dis. 2023 Sep;107(1):115973. doi: 10.1016/j.diagmicrobio.2023.115973. Epub 2023 May 5.
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.
鉴于世界卫生组织的“终止结核病”战略，我们开发了一种非侵入性、基于尿液的 ELISA 检测方法，针对两种结核分枝杆菌抗原，即 MPT51 和 MPT64，用于诊断肺外结核（EPTB）。将疑似 EPTB 患者（n=137）[胸腔结核、腹部结核和结核性脑膜炎]分为“明确”EPTB（n=10）[Xpert-MTB/RIF 和/或培养阳性]、“可能”EPTB（n=77）和“非 EPTB”（n=50）组，使用明确的综合参考标准。使用 ELISA 检测“明确”EPTB 和“非 EPTB”组的结果分别生成 ROC 曲线，并选择截断值，以提供 MPT51 的 86.3%（95%CI：73.3-94.2）特异性和 MPT64 的 92%（95%CI：80.8-97.8）特异性。MPT51-ELISA 和 MPT64-ELISA 的敏感性分别为“明确”EPTB 组的 70%（95%CI：34.7-93.3）和 90%（95%CI：55.5-99.7）和“可能”EPTB 组的 32.5%（95%CI：22.2-44.1）和 30.8%（95%CI：20.8-42.2）。将两种 ELISA 的结果结合起来，在“明确”EPTB 组的敏感性为 100%（95%CI：69.1-100），在“可能”EPTB 组的敏感性为 41.6%（95%CI：30.4-53.4），特异性为 80%（95%CI：66.3-89.9）。结果表明，基于尿液的 ELISA 检测方法具有作为 EPTB 诊断筛查试验的潜力。
