Sivakumar R, Singh N, Singh S
Division of Clinical Microbiology, Department of Laboratory Medicine, All India Institute of Medical Sciences, New Delhi, India.
Indian J Pediatr. 2001 Nov;68(11):1043-6. doi: 10.1007/BF02722354.
Human cytomegalovirus infection is highly prevalent in Indian population. It is the commonest congenitally acquired infection causing various anomalies. The diagnosis of infection in neonates is difficult as IgM may not be detected in all cases. The polymerase chain reaction is reported as alternative and better option in these patients. However, there is lack of data to substantiate this preference in a resource poor country like India.
Blood samples from 930 neonates/fetuses were first tested for specific anti-CMV IgM antibodies using mu-capture enzyme linked immunosorbent assay, Mac-ELISA. Nested PCR was first standardised on clinically and therapeutically confirmed cases of CMV disease. In the second phase blood samples randomly from 20 babies suspected of CMV infection were collected for serology and PCR and both tests were run independently. Twenty healthy controls were also included. IgM ELISA and PCR were performed on these samples and results of these 20 samples were compared to evaluate the sensitivity and specificity of each method.
Out of 930 serum samples of suspected congenital CMV infection 188 (20.2%) were found positive for CMV specific IgM antibodies. While comparing the results of 40 paired samples, PCR was found to be highly specific (100%) but less sensitive than Mac-ELISA (95%) with negative predictive value of 100% and positive predictive value of 95%. Thus in congenital CMV infection Mac-ELISA was less costly, less cumbersome and more user friendly.
The Mac-ELISA seem to have parallel sensitivity and specificity as PCR for diagnosing congenital CMV infection.
人巨细胞病毒感染在印度人群中高度流行。它是最常见的先天性获得性感染，可导致各种异常。新生儿感染的诊断很困难，因为并非所有病例都能检测到IgM。聚合酶链反应据报道是这些患者的替代且更好的选择。然而，在像印度这样资源匮乏的国家，缺乏数据来证实这种偏好。
首先使用μ捕获酶联免疫吸附测定法（Mac-ELISA）对930例新生儿/胎儿的血样进行特异性抗巨细胞病毒IgM抗体检测。巢式PCR首先在临床和治疗上确诊的巨细胞病毒病病例上进行标准化。在第二阶段，随机收集20名疑似巨细胞病毒感染婴儿的血样进行血清学和PCR检测，两项检测独立进行。还纳入了20名健康对照。对这些样本进行IgM ELISA和PCR检测，并比较这20个样本的结果，以评估每种方法的敏感性和特异性。
在930份疑似先天性巨细胞病毒感染的血清样本中，188份（20.2%）被发现巨细胞病毒特异性IgM抗体呈阳性。在比较40对样本的结果时，发现PCR具有高度特异性（100%），但敏感性低于Mac-ELISA（95%），阴性预测值为100%，阳性预测值为95%。因此，在先天性巨细胞病毒感染中，Mac-ELISA成本更低、操作更简便且更易于使用。
Mac-ELISA在诊断先天性巨细胞病毒感染方面似乎具有与PCR相当的敏感性和特异性。
