实时荧光定量RT-PCR与ELISA检测孕妇血清风疹病毒的比较分析

Comparison of real-time fluorescence quantitative RT-PCR for detecting rubella virus RNA in sera of pregnant women with ELISA of IgM antibodies for diagnosis of rubella disease

目的应用TaqMan实时荧光定量RT-PCR技术定量检测孕妇血清标本中风疹病毒RNA,并与ELISA法比较其敏感度与特异度,为孕妇早期风疹病毒检测提供迅速准确的方法。方法收集126例已确诊风疹病毒阳性孕妇血清标本与107例女性健康查体者血清标本,同时进行实时荧光定量RT-PCR核酸检测与风疹病毒ELISA法IgM抗体检测,比较两种方法的敏感度与特异度。结果以细胞培养法为金标准,实时荧光定量RT-PCR法敏感度为92.9%,特异度为98.1%。ELISA IgM抗体法的敏感度和特异度分别为97.6%,86.9%。两种方法的敏感度无显著性差异(p>0.05),实时荧光定量RT-PCR法的特异度明显高于ELISA IgM抗体法(p<0.01)。结论实时荧光定量RT-PCR简便快捷、敏感性高、特异性高、定量准确,在临床风疹病毒基因检测中具有很大的应用潜力。

Objective： To determine the rubella virus RNA in pregnant women by real-time fluorescence quantitative polymerase chain reaction（FQ-PCR）,and to provide a reliable assay for the early prenatal diagnosis of pregnant women with rubella infection.Methods： 126 sera samples of pregnant women patients and 107 sera samples of healthy persons as contrasts were collected.Rubella virus RNA was detected by FQ-PCR,and the rubella virus IgM antibody was assayed by ELISA.Results： The sensitivity and the specificity of FQ-PCR were 92.9% and 98.1%,respectively.While the sensitivity and the specificity of ELISA were 97.6% and 86.9% respectively.The sensitivity of FQ-PCR was similar to that of ELISA（P0.05）,while the specificity of FQ-PCR was higher than that of ELISA（P0.01）.Conclusion： FQ-PCR is a simple,rapid,sensitive,and specific method for detection of the rubella virus infection.