title: Real-time PCR versus viral culture on urine as a gold standard in the diagnosis of congenital cytomegalovirus infection.
abstract: BACKGROUND
  Cytomegalovirus (CMV) infection is the most common cause of congenital infection. Whereas CMV PCR has replaced viral culture and antigen detection in immunocompromised patients because of higher sensitivity, viral culture of neonatal urine is still referred to as the gold standard in the diagnosis of congenital CMV infection.
  
  
  OBJECTIVE
  To compare real-time CMV PCR with shell vial culture on urine in the diagnosis of congenital CMV, in a multicenter design.
  
  
  METHODS
  A series of neonatal urines (n=340), received for congenital CMV diagnostics and routinely assessed with shell vial CMV culture, was retrospectively tested by real-time CMV PCR.
  
  
  RESULTS
  The proportion of newborns found to be congenitally infected by real-time CMV PCR was 8.2% (28/340, 95%CI 5.6-11.8%), and 7.4% (25/340, 95%CI 4.9-10.8%) by rapid culture. When considering rapid culture as reference, real-time PCR was highly sensitive (100%), whereas sensitivity of rapid culture was 89.3% when considering real-time PCR as reference.
  
  
  CONCLUSIONS
  Our results, supported by analytical and clinical data on CMV DNA detection in neonatal urine, suggest enhanced sensitivity of recent PCR techniques when compared to viral culture. There is considerable rationale to favor real-time CMV PCR as a gold standard in the diagnosis of congenital CMV infection. A large-scale study combining both laboratory and clinical data is required to determine the exact time frame for sampling of neonatal urine when using real-time PCR.
authors.affiliation: Department of Medical Microbiology, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands. jjcdevries@lumc.nl
authors.forename: Jutte J C
authors.initials: JJ
authors.lastname: de Vries
authors.forename: Annemiek A
authors.initials: AA
authors.lastname: van der Eijk
authors.forename: Katja C
authors.initials: KC
authors.lastname: Wolthers
authors.forename: Lisette G
authors.initials: LG
authors.lastname: Rusman
authors.forename: Suzan D
authors.initials: SD
authors.lastname: Pas
authors.forename: Richard
authors.initials: R
authors.lastname: Molenkamp
authors.forename: Eric C
authors.initials: EC
authors.lastname: Claas
authors.forename: Aloys C M
authors.initials: AC
authors.lastname: Kroes
authors.forename: Ann C T M
authors.initials: AC
authors.lastname: Vossen
mesh_terms: D003587:Cytomegalovirus / Q000235:genetics* / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000151:congenital / Q000175:diagnosis* / Q000821:virology; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D060888:Real-Time Polymerase Chain Reaction / Q000592:standards*; D012680:Sensitivity and Specificity; D014556:Urine / Q000821:virology*; D014776:Virus Cultivation / Q000592:standards