Rafi W, Venkataswamy M M, Nagarathna S, Satishchandra P, Chandramuki A
Department of Neuromicrobiology, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India.
Int J Tuberc Lung Dis. 2007 Feb;11(2):209-14.
Tuberculous meningitis (TBM) is the commonest form of neurotuberculosis in the Indian subcontinent. Rapid laboratory confirmation of TBM is important for the institution of early treatment and to avoid associated morbidity and mortality. The polymerase chain reaction (PCR) is the most widely applied alternative rapid diagnostic technique for TBM.
To evaluate the efficacy of an in-house developed IS6110 uniplex PCR (uPCR) in the diagnosis of TBM.
A prospective, blinded study was conducted in a large sample base of 677 cerebrospinal fluid samples from 677 patients with clinically suspected TBM.
All culture-positive samples (n = 136) were positive (100%) by the PCR assay. The assay was found to be positive in 70% (n = 541) of the samples with a clinical diagnosis of TBM. The assay had an observed sensitivity of 76.37% (negative predictive value 59.90%) and a specificity of 89.18% (positive predictive value 94.69%). A diagnostic accuracy of 80% (kappa 0.57) was seen in patients with a clinical diagnosis of TBM. Statistical significance was observed, as patients with a clinical diagnosis of TBM were found to be 9.38 times more likely to be PCR-positive (OR 9.38, chi2 = 149.94, P < 0.001).
The performance of the in-house IS6110 uPCR assay merits its use as a sensitive and specific tool for the rapid diagnosis of TBM.
结核性脑膜炎（TBM）是印度次大陆最常见的神经结核形式。TBM的快速实验室确诊对于尽早开始治疗以及避免相关的发病率和死亡率很重要。聚合酶链反应（PCR）是应用最广泛的TBM快速诊断替代技术。
评估自行研发的IS6110单重PCR（uPCR）在TBM诊断中的效能。
对来自677例临床疑似TBM患者的677份脑脊液样本进行了一项前瞻性、盲法研究。
所有培养阳性样本（n = 136）通过PCR检测均为阳性（100%）。在临床诊断为TBM的样本中，该检测方法在70%（n = 541）的样本中呈阳性。该检测方法的观察灵敏度为76.37%（阴性预测值为59.90%），特异性为89.18%（阳性预测值为94.69%）。临床诊断为TBM的患者诊断准确率为80%（kappa值为0.57）。观察到具有统计学意义，因为临床诊断为TBM的患者PCR阳性的可能性是其他患者的9.38倍（比值比9.38，卡方值 = 149.94，P < 0.001）。
自行研发的IS6110 uPCR检测方法的性能使其可作为TBM快速诊断的灵敏且特异的工具。
