title: Performance characteristics of the polymerase chain reaction assay to confirm clinical meningococcal disease.
abstract: BACKGROUND
  Confirmation of clinical meningococcal disease (MCD) is essential for management of patients, contacts, and outbreaks. Blood and CSF cultures, the traditional gold standard diagnostic tests, have been adversely affected by preadmission parenteral penicillin and fewer lumbar punctures. Rapid, reliable serogroup determination without the need to grow isolates could improve laboratory confirmation of MCD.
  
  
  OBJECTIVE
  To determine performance characteristics of the currently available meningococcal polymerase chain reaction (PCR) assays in a clinical setting.
  
  
  METHODS
  Prospective study of 319 children presenting with a suspected diagnosis of MCD (fever and a rash, or suspected bacterial meningitis) over a 16 month period.
  
  
  RESULTS
  A total of 166 (52% of all) children had clinical MCD: diagnosis was confirmed microbiologically in 119 (72%) of these. Performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value) in confirmation of clinical MCD were respectively (95% confidence interval): blood culture 31% (24-38%), 100%, 57% (49-65%), 100%; blood PCR 47% (39-55%), 100%, 65% (58-73%), 100%; any test positive 72% (65-79%), 100%, 77% (70-84%), 100%.
  
  
  CONCLUSIONS
  Meningococcal DNA detection in blood or CSF by PCR is a useful method of diagnosis of MCD. PCR of peripheral blood performs better than blood culture. In a child with clinically suspected MCD, PCR assays, bacterial antigen tests, and oropharyngeal swabbing for meningococcal carriage should be performed in addition to blood or CSF culture, to improve case confirmation.
authors.affiliation: Institute of Child Health, Royal Liverpool Children's Hospital, Alder Hey, Eaton Road, Liverpool L12 2AP, UK. edcarrol@liverpool.ac.uk
authors.forename: E D
authors.initials: ED
authors.lastname: Carrol
authors.forename: A P
authors.initials: AP
authors.lastname: Thomson
authors.forename: P
authors.initials: P
authors.lastname: Shears
authors.forename: S J
authors.initials: SJ
authors.lastname: Gray
authors.forename: E B
authors.initials: EB
authors.lastname: Kaczmarski
authors.forename: C A
authors.initials: CA
authors.lastname: Hart
mesh_terms: D000942:Antigens, Bacterial / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000097:blood / Q000175:diagnosis*; D016133:Polymerase Chain Reaction / Q000379:methods / Q000592:standards*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D006113:United Kingdom
chemical_list: D000942:Antigens, Bacterial