title: [Evaluation of the LightCycler® SeptiFast test in newborns and infants with clinical suspicion of sepsis].
abstract: BACKGROUND
  Neonatal sepsis is a significant cause of morbidity and mortality. Early diagnosis and prompt antimicrobial therapy are crucial for a favorable outcome of the newborn child. Blood culture, the current "gold standard" method for diagnosing bloodstream infections, has a low sensitivity in newborns. We evaluated the multiplex real-time PCR LightCycler(®) SeptiFast (LC-SF) for detection of bloodstream infections in newborns, compared with conventional blood culture.
  
  
  METHODS
  A total of 42 blood samples were obtained from 35 subjects presenting with a febrile episode and hospitalized in neonatal intensive care unit at Hospital Universitario Virgen de las Nieves. Two samples were collected during each febrile episode in order to carry out LC-SF assay and blood culture, respectively.
  
  
  RESULTS
  Sensitivity and specificity of 79% and 87%, respectively, compared with clinical diagnosis, were obtained for LC-SF. Contamination rate of blood cultures was 16.7%, mainly due to coagulase-negative staphylococci (CoNS) and viridans groups of streptococci. Contamination rate of LC-SF by CoNS was 2.4%. Concordance between LC-SF and blood culture was moderate (kappa index: 0.369). LC-SF demonstrated a higher concordance (kappa index: 0.729) with the final clinical diagnosis than blood culture (kappa index: 0.238).
  
  
  CONCLUSIONS
  LC-SF assay could be a useful diagnostic tool, along with a conventional blood culture, in newborn, for confirming or ruling out those cases that blood culture could not determine, shortening the time to result to 7 hours.
authors.affiliation: Departamento de Microbiología, Facultad de Medicina, Universidad de Sevilla, Sevilla, España. etorresev@gmail.com
authors.forename: Eva
authors.initials: E
authors.lastname: Torres-Martos
authors.forename: Mercedes
authors.initials: M
authors.lastname: Pérez-Ruiz
authors.forename: Irene
authors.initials: I
authors.lastname: Pedrosa-Corral
authors.forename: Manuela
authors.initials: M
authors.lastname: Peña-Caballero
authors.forename: María Manuela
authors.initials: MM
authors.lastname: Jiménez-Valera
authors.forename: María Dolores
authors.initials: MD
authors.lastname: Pérez-Ramírez
authors.forename: José María
authors.initials: JM
authors.lastname: Navarro-Marí
mesh_terms: D001431:Bacteriological Techniques; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D060888:Real-Time Polymerase Chain Reaction; D012189:Retrospective Studies; D018805:Sepsis / Q000097:blood* / Q000175:diagnosis*