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Lessons derived from a 3-year congenital cytomegalovirus screening programme in Israel: a prospective
Smadar Eventov Friedman1, Noa Ofek Shlomai1, Esther Oiknine-Djian2
1Department of Neonatology, Hadassah and Hebrew University Medical Center, Jerusalem, Israel; Faculty of Medicine, Hebrew University, Jerusalem, Israel.
The Lancet. Infectious Diseases
|December 13, 2025
Summary
Universal screening for congenital cytomegalovirus (cCMV) using pooled saliva testing is feasible and identifies many infants missed by targeted approaches. This method enables early diagnosis and treatment, improving outcomes for newborns with cCMV.
Area of Science:
- Public Health
- Virology
- Neonatal Screening
Background:
- Congenital cytomegalovirus (cCMV) is a primary cause of pediatric neurological and hearing impairments.
- No standardized public health screening strategy currently exists for cCMV.
- A novel saliva-pooling method was developed to assess universal cCMV screening outcomes.
Purpose of the Study:
- To evaluate the performance and feasibility of pooled-saliva testing for cCMV over time.
- To determine the actual prevalence of cCMV and identify infants missed by expanded-targeted screening.
- To attribute cCMV and its sequelae to primary or non-primary maternal infection.
Main Methods:
- A prospective study involving 48,556 newborns screened via pooled-saliva real-time PCR (rtPCR).
- Confirmatory urine rtPCR for infants with positive saliva tests.
- Comparison of universal screening detection rates against expanded-targeted strategies.
Main Results:
- 176 newborns (3.6/1000) tested positive for cCMV.
- Pooled testing demonstrated 5.82 efficiency with minimal sensitivity loss.
- 57% of cCMV cases would have been missed by expanded-targeted screening, including symptomatic infants.
Conclusions:
- Pooled-saliva testing is a sensitive and feasible method for universal cCMV screening.
- Universal screening facilitates early diagnosis and treatment, informing public health guidelines.
- Further cost-benefit analyses are recommended for widespread implementation.
