Congenital Cytomegalovirus Testing Outcomes From the ValEAR Trial

Area of Science:

• Neonatal screening
• Infectious disease surveillance
• Public health

Background:

• Congenital cytomegalovirus (cCMV) is a leading infectious cause of non-genetic hearing loss in newborns.
• Early detection and intervention are crucial for mitigating cCMV-related long-term health issues.
• Evaluating different newborn screening strategies is essential for optimizing cCMV detection rates.

Purpose of the Study:

• To compare the positivity rates of cCMV testing across universal, hearing-targeted CMV testing (HT-cCMV), and delayed targeted dried blood spot (DBS) newborn screening programs.
• To identify characteristics associated with successful HT-cCMV screening programs.

Main Methods:

• A prospective survey was conducted across multiple institutions involving birth hospitals participating in the NIH ValEAR clinical trial.
• Hospitals were surveyed on their implementation of universal, HT-cCMV, and DBS testing for cCMV.
• A mixed-methods model analyzed associations between successful HT-cCMV screening and specific screening protocols.

Main Results:

• Data from 82 hospitals (Feb 2019-Dec 2021) revealed cCMV positivity rates of 0.5% (universal, n=7670), 1.5% (HT-cCMV, n=9017), and 7.3% (DBS, n=535).
• Universal CMV screening positivity was lower during the COVID-19 pandemic, though not statistically significant across any tested approach.
• Successful HT-cCMV programs were linked to unique order sets and rigorous post-testing protocols.

Conclusions:

• Positivity rates for cCMV screening differed significantly among the three evaluated approaches.
• The observed rates are comparable to existing literature.
• Institutions with specific order sets, where primary care physicians order tests and nurses facilitate collection, demonstrated higher HT-cCMV testing rates.