The Role of Expanded Targeted Testing in Enhancing Early Detection of Congenital Cytomegalovirus: A Cohort Study

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BACKGROUND: In the absence of a consensus on universal newborn congenital cytomegalovirus (cCMV) screening, institutions have adopted a strategy of testing infants referred from newborn hearing screening (NHS). We aimed to evaluate the impact of an expanded cCMV testing protocol in detecting cCMV, the diagnostic yield of various testing indications, and the rate of infants with sensorineural hearing loss. METHODS: We reviewed audiological and medical records of infants born at Sheba Medical Center over a 6-year period, tested for cCMV ≤21 days due to NHS referral, maternal serology suggestive of CMV infection during pregnancy and/or clinical symptoms. The diagnosis was based on saliva DNA and confirmed by urine. RESULTS: Of 3541 infants (5.6% of all 63,404 live births) who met the expanded testing criteria, 3418 infants were screened for cCMV. One hundred seventy-five cCMV-positive cases accounted for 5.1% [95% confidence interval (CI): 4.4-5.9] of the cohort and 0.3% (95% CI: 0.2-0.3) of all live births. Maternal seroconversion was the most common testing indication (55.7%) and had the highest diagnostic yield for cCMV (N = 154, yield = 8.1%). NHS referral was the second most frequent indication (29.6%) but had the lowest diagnostic yield (N = 22, yield = 2.2%). Twenty-two infants (13%, 95% CI: 8-18) of cCMV-positive infants were diagnosed soon after birth with sensorineural hearing loss, 10 (45%) of whom were missed by the NHS. CONCLUSIONS: Our findings confirm the effectiveness of an expanded cCMV screening approach, consistent with recent European congenital cytomegalovirus initiative recommendations, and support its consideration for broader application in countries where it is not yet standard practice.

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