ArticleFrontiers in pediatrics2025
A high-sensitivity, high-throughput newborn screening assay for congenital cytomegalovirus-is it time for universal screening in the United Kingdom?
Article in Frontiers in pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Congenital cytomegalovirus (cCMV) is the leading cause of neurodevelopmental and hearing impairment resulting from Methods: A high-sensitivity, high-throughput commercial CMV PCR kit targeting the RRP30 control gene and a conserved region of CMV DNA was provided by Revvity and tested in three population groups: (1) leftover dried blood spot (DBS) samples from the UK newborn screening programme, (2) DBS samples from children with CMV viraemia unrelated to cCMV, and (3) DBS and dried saliva samples from infants with and without cCMV. Results: Of 3,345 anonymised newborn DBS samples analysed, CMV was detected in 22 cases (0.66%), with a mean cycle threshold value of 36.70 (range 31.87-41.68). Assay development demonstrated a sensitivity of 2.04 CMV IU per reaction. This level of sensitivity was replicated using DBS samples prepared from infant/child blood samples with known levels of CMV, suggesting that the sensitivity reflects 2,000-3,000 CMV IU/mL blood. Discussion: We demonstrated high analytical sensitivity of the qPCR assay with an optimal extraction protocol, making it an effective strategy for cCMV screening using DBS samples. These data suggest a potential cCMV incidence rate of up to 0.66% in the United Kingdom, equivalent to 3,960 infants per year, 25% of whom may develop long-term sequelae, which could be improved through early diagnosis and treatment.
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