孕期巨细胞病毒（CMV）的新发或再发感染导致新生儿先天感染并影响其神经发育，造成约15~20%患儿出现耳聋、智障等永久性缺陷。过去曾认为我国等CMV高流行区由于大多数妇女孕前已有抗体，因此先天感染威胁较小。然而近年来研究发现阳性孕妇中约1%出现新生儿先天感染。传统的IgM和IgG抗体检测用于孕妇再发感染诊断的灵敏度和特异度广受质疑，亟需发展鉴别母婴传播高危群体的新方法。本课题组曾利用CMV PP150抗原对自然人群系列血清进行IgG抗体检测，发现再发感染风险与基线抗体水平密切相关（RR=11.1，95%CI 7.7-14.3），提示用于鉴别CMV母婴传播高危群体的可能性。本课题拟建立孕早期孕妇队列并随访孕期活动性感染和新生儿先天感染情况，探讨与基线抗体水平的相关性，研究这一新方法对母婴传播高危群体的预测价值，并发展出可便捷定量的化学发光法试剂，为CMV先天感染的防控提供新思路和新工具。

Primary or recurrent infection of cytomegalovirus in pregnant woman leads to congenital infection in newborn and results in the permanent sequelae in 15~20% of the latter. The dogma that congenitally infected children who are born to women with preexisting antibodies have normal outcomes has led to inattention to congenital CMV in developing countries. Emerging data from highly seropositive populations, which are usually in developing countries, however, suggest that not only is the rate of congenital CMV infection higher than in developed countries but it is an important cause of hearing loss. The utility of traditional IgM and IgG detection in pregnant is wildly questioned for their low sensitivity and specificity in detecting maternal recurrent CMV infection. It is urgently needed to develop new method to identify population with high-risk of intrauterine transmission. Using a recombinant PP150 antigen of CMV, we had detected the anti-CMV IgG levels in serial sera collected from a natural population. The results showed that the baseline antibody level is closely associated with the risk of recurrent CMV infection (risk ratio=11.1, 95%CI 7.7-14.3). The findings suggest the potential usage of quantifying maternal anti-PP150 IgG levels in predicting the risk of congenital infection. In this project, we plan to establish a longitudinal cohort of women who are in their early phase of pregnancy. The cohort will be prospectively followed up for the occurrence of active CMV infection during their pregnancy and also the occurrence of congenital infection in their newborns. The primary object is to validate the value of baseline anti-PP150 levels in prediction the risk of congenital infection. The second object is to develop an easily-operate assay to quantitative the anti-PP150 levels based on chemical luminescent principle.