Biochemistry Research Laboratory, Central India Institute of Medical Sciences, Nagpur, Maharashtra, India.
PLoS One. 2013 Sep 12;8(9):e74652. doi: 10.1371/journal.pone.0074652. eCollection 2013.
Malnutrition is a major risk factor for the development of tuberculosis (TB). In India, Melghat is among the tribal regions which consist of highest number of malnutrition cases. Because of the paucity of TB data from these malnourished areas there is an urgent need for the development and evaluation of improved TB diagnostic tests. In the present study, three in house developed diagnostic tests namely TB-Ag(antigen) ELISA, Adenosine deaminase (ADA) estimation and IS6110 polymerase chain reaction (PCR) assay were investigated for the detection of Mycobacterium tuberculosis (M. tb.) infection.
For investigation, blood samples were collected from 128 study subjects from six villages of Melghat tribal area and evaluated using three in house developed assays, namely TB-Ag ELISA, ADA estimation and IS6110 PCR.
The TB-Ag ELISA method yielded 83% sensitivity and 94% specificity. The ADA and PCR assay gave a sensitivity of 61% and 49% and specificity of 62% and 98% respectively. A considerable good agreement of 82.81% (k=0.472) between TB-Ag ELISA and PCR was observed. The overall sensitivity of TB-Ag ELISA was significantly higher (p<0.05) than the ADA and PCR while PCR yielded highest specificity among all the three evaluated tests.
We concluded that the routine use of TB-Ag ELISA can be useful for screening of suspected TB patients in the malnourished population where sophisticated laboratory set up is difficult.
营养不良是结核病(TB)发展的主要危险因素。在印度,梅尔格特是部落地区之一,营养不良病例最多。由于这些营养不良地区缺乏结核病数据,因此迫切需要开发和评估改进的结核病诊断测试。在本研究中,我们研究了三种内部开发的诊断测试,即 TB-Ag(抗原)ELISA、腺苷脱氨酶(ADA)估计和 IS6110 聚合酶链反应(PCR)检测,以检测结核分枝杆菌(M. tb.)感染。
为了进行研究,从梅尔格特部落地区的六个村庄采集了 128 名研究对象的血液样本,并使用三种内部开发的检测方法进行了评估,即 TB-Ag ELISA、ADA 估计和 IS6110 PCR。
TB-Ag ELISA 方法的灵敏度为 83%,特异性为 94%。ADA 和 PCR 检测的灵敏度分别为 61%和 49%,特异性分别为 62%和 98%。TB-Ag ELISA 和 PCR 之间观察到相当好的一致性为 82.81%(k=0.472)。TB-Ag ELISA 的总体灵敏度明显高于 ADA 和 PCR,而 PCR 在所有三种评估的检测方法中具有最高的特异性。
我们得出结论,在难以建立复杂实验室的营养不良人群中,常规使用 TB-Ag ELISA 可以有助于筛选疑似结核病患者。