title: Prospective identification of congenital cytomegalovirus infection in newborns using real-time polymerase chain reaction assays in dried blood spots.
abstract: BACKGROUND
  Congenital cytomegalovirus (CMV) infection is a public health issue, and implementation of neonatal screening has been debated. Detection of CMV DNA by polymerase chain reaction (PCR) of dried blood spots (DBS) routinely collected for metabolic screening from all newborns has been proposed for congenital CMV infection screening. The goal of this study was to prospectively assess the performance of 2 CMV PCR assays of DBS for CMV neonatal screening in a selected population of neonates.
  
  
  METHODS
  We studied prospective congenital CMV screening in a population of neonates either born with symptoms compatible with congenital CMV or born to mothers with a history of primary infection during pregnancy. For each neonate, 2 CMV PCR assays of DBS were blindly performed in parallel with a gold standard technique (ie, CMV PCR of a urine sample).
  
  
  RESULTS
  Two hundred seventy-one neonates were studied, and CMV infection, defined by a positive urine sample in the first week of life, was confirmed in 64 (23.6%). Nineteen infected (29.7%) neonates were symptomatic, and 45 (70.3%) were asymptomatic. The ranges of sensitivity, specificity, positive predictive value, and negative predictive value for the 2 CMV PCR assays of DBS were 95.0%-100%; 98.1%-99.0%; 94.1%-96.9%, and 98.5%-100%, respectively.
  
  
  CONCLUSIONS
  The sensitivity and specificity of both CMV PCR assays of DBS to identify congenital CMV were very high in this population of neonates with a high risk of sequelae. These new data should be considered in the ongoing debate on the appropriateness of the use of DBS as a sample to screen for congenital CMV infection.
authors.affiliation: Laboratoire de Virologie, Hôpital Necker-Enfants-Malades, Centre National de Référence du Cytomégalovirus-Laboratoire Associé, Paris, France. marianne.leruez@nck.aphp.fr
authors.forename: Marianne
authors.initials: M
authors.lastname: Leruez-Ville
authors.forename: Christelle
authors.initials: C
authors.lastname: Vauloup-Fellous
authors.forename: Sophie
authors.initials: S
authors.lastname: Couderc
authors.forename: Sophie
authors.initials: S
authors.lastname: Parat
authors.forename: Christine
authors.initials: C
authors.lastname: Castel
authors.forename: Véronique
authors.initials: V
authors.lastname: Avettand-Fenoel
authors.forename: Tiffany
authors.initials: T
authors.lastname: Guilleminot
authors.forename: Liliane
authors.initials: L
authors.lastname: Grangeot-Keros
authors.forename: Yves
authors.initials: Y
authors.lastname: Ville
authors.forename: Sophie
authors.initials: S
authors.lastname: Grabar
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Magny
mesh_terms: D001769:Blood / Q000821:virology*; D003587:Cytomegalovirus / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000151:congenital / Q000175:diagnosis*; D004279:DNA, Viral / Q000097:blood; D003890:Desiccation; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D008403:Mass Screening / Q000379:methods; D016133:Polymerase Chain Reaction / Q000379:methods*; D011247:Pregnancy; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D014773:Virology / Q000379:methods*
chemical_list: D004279:DNA, Viral