Lessons derived from a 3-year congenital cytomegalovirus screening programme in Israel: a prospective population-based cohort study

Smadar Eventov Friedman ¹, Noa Ofek Shlomai ¹, Esther Oiknine-Djian ²

¹Department of Neonatology, Hadassah and Hebrew University Medical Center, Jerusalem, Israel; Faculty of Medicine, Hebrew University, Jerusalem, Israel.
²Faculty of Medicine, Hebrew University, Jerusalem, Israel; Clinical Virology Unit, Department of Clinical Microbiology and Infectious Diseases, Hadassah Hebrew University Medical Center, Hebrew University Faculty of Medicine, Jerusalem, Israel; Lautenberg Center for General and Tumor Immunology, Jerusalem, Israel.
³Clinical Virology Unit, Department of Clinical Microbiology and Infectious Diseases, Hadassah Hebrew University Medical Center, Hebrew University Faculty of Medicine, Jerusalem, Israel.
⁴Faculty of Medicine, Hebrew University, Jerusalem, Israel; Pediatric Infectious Diseases, Pediatric Division, Hadassah Hebrew University Medical Center, Jerusalem, Israel.
⁵Clinical Virology Unit, Department of Clinical Microbiology and Infectious Diseases, Hadassah Hebrew University Medical Center, Hebrew University Faculty of Medicine, Jerusalem, Israel; School of Computer Science and Engineering, Hebrew University of Jerusalem, Jerusalem, Israel; Department of Microbiology and Molecular Genetics, Institute for Medical Research Israel-Canada, Faculty of Medicine, The Hebrew University of Jerusalem, Israel.
⁶Speech and Hearing Center, Hadassah Hebrew University Medical Center, Jerusalem, Israel; Department of Communication Disorders, Jerusalem Multidisciplinary College, Jerusalem, Israel.
⁷Pediatric Radiology Unit, Department of Radiology, Hadassah Hebrew University Medical Center, Jerusalem, Israel.
⁸Moderna Therapeutics, Cambridge, MA, USA.
⁹Medison Pharma, Petah Tikva, Israel.
¹⁰Faculty of Medicine, Hebrew University, Jerusalem, Israel; Braun School of Public Health and Community Medicine, Hadassah Medical Organization, Jerusalem, Israel.
¹¹School of Computer Science and Engineering, Hebrew University of Jerusalem, Jerusalem, Israel; Department of Microbiology and Molecular Genetics, Institute for Medical Research Israel-Canada, Faculty of Medicine, The Hebrew University of Jerusalem, Israel.

⁰Department of Neonatology, Hadassah and Hebrew University Medical Center, Jerusalem, Israel; Faculty of Medicine, Hebrew University, Jerusalem, Israel.

The Lancet. Infectious Diseases +

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December 13, 2025

View abstract on PubMed

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.