Congenital Cytomegalovirus (CMV) infection is a leading cause of birth defects and developmental disabilities in the U.S., affecting thousands of children each year. Notably, the majority of children acquire congenital CMV from non-primary maternal CMV infection rather than primary infection. Thus, determining the maternal serostatus in the field may further our understanding of the association between CMV infection status and worse pregnancy outcome, and risk stratify pregnant women during gestation. Current methods to detect maternal CMV serostatus are labor intensive and require sophisticated equipment, dedicated laboratory space, and trained technicians. We propose developing a point-of-care (POC) test for rapid screening of maternal CMV serostatus. A rapid, on-site test for CMV serostatus screening in biospecimens would: (1) allow for immediate counseling and confirmatory testing, and (2) avoid having to create new laboratory infrastructure for biospecimen testing. Alternatively, a rapid POC test that could be utilized during initial study screening visits would permit the efficient identification and enrollment for CMV vaccine testing.
Congenital CMV infection is the most common congenital viral infection and a leading cause of birth defects and developmental disabilities. The goal of this project is to develop a rapid POC test to characterize CMV serostatus in pregnant women in order to determine the influence of CMV on neonatal outcomes. Alternatively, a rapid POC test that could be utilized during initial study screening visits would permit the efficient identification and enrollment for CMV vaccine testing.
