Kashyap Rajpal S, Rajan Anju N, Ramteke Sonali S, Agrawal Vijay S, Kelkar Sanjivani S, Purohit Hemant J, Taori Girdhar M, Daginawala Hatim F
Biochemistry Research Laboratory, Central India Institute of Medical Sciences, Nagpur, India.
BMC Infect Dis. 2007 Jul 10;7:74. doi: 10.1186/1471-2334-7-74.
Diagnosis of tuberculosis (TB) remains problematic despite many new advanced diagnostic methods. A reliable and rapid diagnostic test, which could be performed in any standard pathology laboratory, would help to obtain definitive early diagnoses of TB. In the present study we describe a prospective evaluation for demonstrating Antigen (Ag) 85 complex in the sera from TB patients.
Indirect ELISA, employing monoclonal antibodies (mAb) against the purified Ag 85 complex, was used to demonstrate Ag 85 complex in sera from TB patients. Serum samples were obtained from 197 different groups of patients: confirmed TB {n = 24}, clinically diagnosed TB {n = 104}, disease controls {n = 49} and healthy controls {n = 20}. Receiver operating curve (ROC) was used to calculate the cut off value and comparison between TB and non-TB groups were done by the chi-square test.
The indirect ELISA method, using an mAb against Ag 85 complex, yielded 82% sensitivity (95% confidence interval [CI] 67 to 93%) and 86% specificity (95% CI, 57 to 98%) for the diagnosis of TB. The serum positivities for Ag 85 complex in cases of confirmed and clinically diagnosed TB patients were 96% (23/24) and 79% (82/104) respectively, while the positivity for patients in the non-tuberculosis group was 14% (10/69).
The detection of Ag 85 complex in sera from TB patients by indirect ELISA using mAb against purified Ag 85 complex gives a reliable diagnosis and can be used to develop an immunodiagnostic assay with increased sensitivity and specificity.
尽管有许多新的先进诊断方法，但结核病（TB）的诊断仍然存在问题。一种可靠且快速的诊断测试，能够在任何标准病理实验室进行，将有助于获得结核病的确切早期诊断。在本研究中，我们描述了一项前瞻性评估，以证明结核病患者血清中的抗原（Ag）85复合物。
采用针对纯化的Ag 85复合物的单克隆抗体（mAb）的间接ELISA法，用于证明结核病患者血清中的Ag 85复合物。血清样本取自197个不同组别的患者：确诊结核病患者{n = 24}、临床诊断结核病患者{n = 104}、疾病对照{n = 49}和健康对照{n = 20}。采用受试者工作特征曲线（ROC）计算临界值，并通过卡方检验对结核病组和非结核病组进行比较。
使用针对Ag 85复合物的mAb的间接ELISA法，对结核病诊断的敏感性为82%（95%置信区间[CI]67至93%），特异性为86%（95%CI，57至98%）。确诊和临床诊断的结核病患者血清中Ag 85复合物的阳性率分别为96%（23/24）和79%（82/104），而非结核病组患者的阳性率为14%（10/69）。
使用针对纯化的Ag 85复合物的mAb通过间接ELISA法检测结核病患者血清中的Ag 85复合物可提供可靠的诊断，并可用于开发具有更高敏感性和特异性的免疫诊断检测方法。
