title: Universal neonatal cytomegalovirus screening using saliva - report of clinical experience.
abstract: OBJECTIVE
  To analyze the results of a neonatal universal screen for congenital cytomegalovirus (CMV) using saliva real-time polymerase chain reaction (rt-PCR).
  
  
  METHODS
  During one year (15/5/2011-15/5/2012), saliva was collected from 9845 infants (97% of 10,137 newborns). Viral DNA was extracted by Magna-Pure LC (Roche) and was tested for the presence of CMV IE and gB genes. Urine culture was collected from positive infants for confirmation. For all infants with congenital CMV maternal data were collected and head ultrasound, blood count, liver enzymes, retinal examination and auditory brainstem response testing were performed. Parents were notified in advance and had the option to avoid screening. The ethical committee approved retrospective analysis of the data.
  
  
  RESULTS
  Fifty six infants (0.57%) had a positive saliva assay. Of these, 47 were confirmed by urine rt-PCR and culture, in another one maternal sero-conversion was documented during pregnancy (48 infants). Twenty-eight mothers (28/47, 60%) had primary infection during pregnancy, 14 (30%) had non-primary infection, and no serological data were obtained from five (10%). Four infants (8.5%), two with prenatal diagnosis of CMV and normal fetal brain imaging and two born to mothers sero-positive before pregnancy, exhibited symptoms related to CMV and were offered antivirals. Hearing impairment was diagnosed in two infants (late onset HI in one case).
  
  
  CONCLUSIONS
  Saliva rt-PCR assay is a feasible and effective means of universal neonatal CMV screening that can detect affected infants who might benefit from treatment and follow-up. The long-term clinical significance of screening and its cost effectiveness are yet to be determined.
authors.affiliation: Pediatric Infectious Disease Unit, The Edmond and Lily Safra Children's Hospital, Chaim Sheba Medical Center, Israel; Department of Pediatrics, Sackler Faculty of Medicine, Tel Aviv University, Israel. Electronic address: galia.barkai@sheba.health.gov.il.
authors.forename: Galia
authors.initials: G
authors.lastname: Barkai
authors.affiliation: Hearing, Speech and Language Center, Chaim Sheba Medical Center, Israel; Department of Communication Disorders, Sackler Faculty of Medicine, Tel Aviv University, Israel.
authors.forename: Daphne
authors.initials: D
authors.lastname: Ari-Even Roth
authors.affiliation: Pediatric Infectious Disease Unit, The Edmond and Lily Safra Children's Hospital, Chaim Sheba Medical Center, Israel; Department of Pediatrics, Sackler Faculty of Medicine, Tel Aviv University, Israel.
authors.forename: Asher
authors.initials: A
authors.lastname: Barzilai
authors.affiliation: Central Virology Laboratory, Ministry of Health, Chaim Sheba Medical Center, Israel; Department of Pediatrics, Sackler Faculty of Medicine, Tel Aviv University, Israel.
authors.forename: Michal
authors.initials: M
authors.lastname: Tepperberg-Oikawa
authors.affiliation: Central Virology Laboratory, Ministry of Health, Chaim Sheba Medical Center, Israel; Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Israel.
authors.forename: Ella
authors.initials: E
authors.lastname: Mendelson
authors.affiliation: Hearing, Speech and Language Center, Chaim Sheba Medical Center, Israel; Department of Communication Disorders, Sackler Faculty of Medicine, Tel Aviv University, Israel.
authors.forename: Minka
authors.initials: M
authors.lastname: Hildesheimer
authors.affiliation: Neonatology, The Edmond and Lily Safra Children's Hospital, Chaim Sheba Medical Center, Israel; Department of Pediatrics, Sackler Faculty of Medicine, Tel Aviv University, Israel.
authors.forename: Jacob
authors.initials: J
authors.lastname: Kuint
mesh_terms: D000328:Adult; D000998:Antiviral Agents; D003587:Cytomegalovirus / Q000235:genetics*; D003586:Cytomegalovirus Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000652:urine / Q000821:virology; D004279:DNA, Viral / Q000235:genetics; D016057:Evoked Potentials, Auditory, Brain Stem / Q000502:physiology; D005260:Female; D015774:Ganciclovir / Q000031:analogs & derivatives / Q000627:therapeutic use; D034381:Hearing Loss / Q000175:diagnosis; D006801:Humans; D017874:Immediate-Early Proteins / Q000235:genetics; D007231:Infant, Newborn; D007557:Israel; D008099:Liver / Q000201:enzymology; D008297:Male; D008403:Mass Screening / Q000379:methods*; D009035:Mothers; D015997:Neonatal Screening / Q000379:methods; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis* / Q000821:virology; D060888:Real-Time Polymerase Chain Reaction; D012160:Retina / Q000502:physiology; D012189:Retrospective Studies; D012463:Saliva / Q000821:virology*; D012698:Serologic Tests; D000077562:Valganciclovir; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D017874:Immediate-Early Proteins; D000077562:Valganciclovir; D015774:Ganciclovir
keywords: Congenital cytomegalovirus; Newborn screening; Polymerase chain reaction