Biochemistry Research Laboratory, Central India Institute of Medical Sciences, Nagpur, India.
Med Sci Monit. 2010 Jun;16(6):CR289-95.
Despite the availability of many investigational methods, diagnosis of Tuberculous meningitis (TBM) is extremely difficult. Polymerase chain reaction (PCR), using specific primers for Mycobacterium tuberculosis (MTB), shows variable sensitivity and specificity. In this study, we assessed the usefulness of the PCR assay for TBM diagnosis and compared it to our in-house enzyme-linked immunosorbent assay (ELISA) based on antigen 85 complex detection.
MATERIAL/METHODS: Cerebrospinal fluid (CSF) samples were obtained from 189 patients in 3 different groups: confirmed TBM (n=13), clinically suspected TBM (n=37), and non-TBM (n=139). A PCR assay was performed using a specific pair of primers designed to amplify the insertion sequence IS6110 in the MTB genome, and it was compared to ELISA, using monoclonal antibodies against the purified Ag 85 complex, to analyze CSF samples and diagnose TBM.
The PCR assay yielded sensitivity and specificity values of 80% and 84%, which are slightly less, but comfortable to the values obtained for the ELISA method (84% and 91%). Interestingly, a combinatorial approach using both methods provided sensitivity and specificity of 88% and 93%.
The PCR assay was found to be as sensitive and specific as the well-established in-house ELISA technique, suggesting that it can be used for TBM diagnosis.
尽管有许多研究方法，但结核性脑膜炎（TBM）的诊断仍然极具挑战性。聚合酶链反应（PCR）使用针对结核分枝杆菌（MTB）的特定引物，其敏感性和特异性存在差异。在这项研究中，我们评估了 PCR 检测方法在 TBM 诊断中的作用，并将其与我们基于抗原 85 复合物检测的内部酶联免疫吸附试验（ELISA）进行了比较。
材料/方法：从 3 组不同的患者中获得了脑脊液（CSF）样本：确诊的 TBM（n=13）、临床疑似 TBM（n=37）和非 TBM（n=139）。使用针对 MTB 基因组中插入序列 IS6110 的特异性引物进行 PCR 检测，并与 ELISA 进行比较，ELISA 采用针对纯化 Ag 85 复合物的单克隆抗体分析 CSF 样本并诊断 TBM。
PCR 检测的敏感性和特异性值分别为 80%和 84%，略低于 ELISA 方法（84%和 91%）。有趣的是，两种方法联合使用的组合方法提供了 88%和 93%的敏感性和特异性。
PCR 检测与成熟的内部 ELISA 技术一样敏感和特异，提示其可用于 TBM 诊断。
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