20.500.12556/DiRROS-30701 Universal dried blood spot screening for congenital cytomegalovirus a Slovenian national implementation pilot Congenital cytomegalovirus infection (cCMV) is the most common congenital infection and an important cause of sensorineural hearing loss and neurodevelopmental impairment, yet many affected infants remain undetected under selective screening approaches. We conducted a prospective national pilot study to evaluate the feasibility and diagnostic yield of universal dried blood spot (DBS)-based screening for cCMV within the Slovenian newborn screening program. DBS samples collected within 72 h of life were tested by polymerase chain reaction (PCR), and screen-positive newborns underwent confirmatory urine PCR within 21 days together with standardized clinical evaluation. Among 5556 screened newborns, 13 (0.23%) screened positive and cCMV was confirmed in 10, corresponding to a lower-bound birth prevalence of 1.80 per 1000 live births (95% confidence interval, 0.98–3.31), because confirmatory testing was limited to DBS-positive newborns. None of the confirmed cases were clinically suspected at birth, and all passed newborn hearing screening. Six infants met protocol-defined criteria for symptomatic cCMV and received valganciclovir. Historical registry-based clinical case ascertainment in Slovenia corresponded to 0.09 detected cases per 1000 live births. These findings demonstrate the feasibility of universal DBS-based cCMV screening within an established newborn screening infrastructure and suggest substantial under-ascertainment under selective clinical detection pathways. cytomegalovirus CMV congenital cytomegalovirus infection newborn screening NBS universal screening dried blood spots DBS public health policy true false true Angleški jezik Ni določen Neznano 2026-07-01 10:58:27 2026-07-01 10:58:28 2026-07-07 08:33:06 0000-00-00 00:00:00 2026 0 0 Nasl. z nasl. zaslona; Opis vira z dne 29. 6. 2026; str. 1-14 issue 3, [article no. ] 48 Vol. 12 2026 0000-00-00 Zaloznikova Objavljeno apc 0000-00-00 0000-00-00 0000-00-00 616-053.2 2409-515X 10.3390/ijns12030048 282929411 RAZ_Erzen_Nika_2026.pdf RAZ_Erzen_Nika_2026.pdf 1 59341655AAA5A7B2C6DCA869E892CB9B ac0c8bcc975056e4f2b2f5ba8952e6c7d057b587b592b5f29bb1840a48e6de0e 0e06b394-75f5-11f1-a2b4-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=47030 https://www.mdpi.com/2409-515X/12/3/48 1 07d023cb-752b-11f1-b0d9-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=46831 Univerzitetni klinični center Ljubljana 0 0 0