Diagnosis of tuberculosis in an Indian population by an indirect ELISA protocol based on detection of Antigen 85 complex: a prospective cohort study.

Diagnosis of tuberculosis in an Indian population by an indirect ELISA protocol based on detection of Antigen 85 complex: a prospective cohort study.
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基于检测抗原85复合物的间接ELISA方案,印度人群中结核病的诊断:一项前瞻性队列研究。

DOI:
10.1186/1471-2334-7-74
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发表时间:
2007-07-10
影响因子:
3.7
通讯作者:
Daginawala, Hatim F.
Daginawala, Hatim F.
中科院分区:
医学3区
文献类型:
--
作者:
Kashyap, Rajpal S.;Rajan, Anju N.;Ramteke, Sonali S.;Agrawal, Vijay S.;Kelkar, Sanjivani S.;Purohit, Hemant J.;Taori, Girdhar M.;Daginawala, Hatim F.

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尽管有许多新的高级诊断方法,但结核病诊断(TB)仍然有问题。可以在任何标准病理实验室中进行的可靠且快速的诊断测试,将有助于获得最终的结核病早期诊断。在本研究中,我们描述了TB患者血清中抗原(AG)85复合物的前瞻性评估。 使用单克隆抗体(MAB)对纯化的Ag 85复合物采用单克隆抗体(MAB)的间接ELISA,用于证明来自结核病患者血清中的Ag 85复合物。从197个不同的患者组中获得血清样品:确认的TB {n = 24},临床诊断为TB {n = 104},疾病对照{n = 49}和健康对照{n = 20}。接收器工作曲线(ROC)用于计算切断值,并通过卡方检验进行结核病和非TB组之间的比较。 使用对Ag 85复合物的MAB的间接ELISA方法产生了82%的敏感性(95%置信区间[CI] 67%至93%)和86%的特异性(95%CI,57至98%)用于诊断TB。在确认和临床诊断的结核病患者的情况下,Ag 85复合物的血清阳性分别为96%(23/24)和79%(82/104),而非结核病组患者的阳性为14%(10/69)。 使用MAB使用MAB对纯化的Ag 85复合物的间接ELISA从TB患者中检测Ag 85复合物可提供可靠的诊断,可用于开发具有更高敏感性和特异性的免疫诊断测定。
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.
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