By Kaisha Gonzalez, PhD
Congenital cytomegalovirus (cCMV) is the most common congenital infection in the United States and a leading cause of childhood hearing loss, yet most affected newborns are asymptomatic at birth. This article examines the clinical consequences of missed diagnoses, including neurodevelopmental delay and a potential association with autism spectrum disorder, and evaluates three primary screening models: targeted, expanded targeted, and universal approaches. It reviews current legislation, emerging policy initiatives, and the performance of molecular diagnostic methods using saliva, urine, and dried blood spots. Practical guidance is provided to help laboratories implement effective, timely, and evidence-based cCMV testing strategies.
LEARNING OBJECTIVES
Upon completion of this article, the reader will be able to:
- Discuss current statistics of congenital cytomegalovirus (cCMV) that affects the newborn population
- List the complications that cCMV can cause later in life
- Differentiate between the three screening processes for cCMV and list the limitations of each
- Discuss current and future laboratory testing methods for the detection of cCMV

Kaisha Gonzalez, PhD is the Regional Director of Scientific Affairs at Diasorin and holds a Ph.D. in Microbiology and Immunology from the University of Rochester School of Medicine and Dentistry. She specializes in molecular diagnostics and infectious diseases, leading scientific outreach initiatives, clinical research collaborations, and
efforts to advance diagnostic solutions through scientific engagement and education. Her work has contributed to raising awareness and addressing key challenges in infectious disease diagnostics through public education, professional presentations, and media outreach.

