Congenital Cytomegalovirus (CMV) infection is a leading cause of birth defects and developmental disabilities in the U.S., affecting thousands of children each year. Current methods (e.g., tissue culture, shell vial assay, single-copy gene PCR methods, etc.) to detect CMV infections are labor intensive and require sophisticated equipment, dedicated laboratory space, and trained technicians. A rapid, on-site test for newborn screening that could detect CMV in clinical specimens would: (1) allow for immediate counseling and additional specimen collection for confirmatory testing, and (2) avoid having to create new laboratory infrastructure for widespread biospecimen testing. We propose developing a point-of-care test for rapid screening of congenital CMV infection. This technology will also result in a significant cost reduction as compared to hospital and clinical pathology laboratory tests. The goal of this project is to develop an inexpensive ($10-15 per sample) and rapid (<30 min from specimen to result) screening assay for primary CMV infections.
The goal of this project is to develop a rapid, point-of-care (POC) assay for newborn screening that could detect CMV in clinical specimens. POC assays to detect neonatal CMV infection in the U.S. are currently not available. If they were available, they would significantly lower the barriers to widespread screening and timely prevention interventions.