title: Evaluation of a diagnostic polymerase chain reaction assay for Neisseria meningitidis in North America and field experience during an outbreak.
abstract: BACKGROUND
  Meningococcal infection has a high public profile because of its dramatic presentation, high fatality rate, and propensity to occur in outbreaks and clusters of cases. Use of a diagnostic polymerase chain reaction (PCR) assay could enhance laboratory confirmation of cases and guide the public health response in North America.
  
  
  OBJECTIVE
  To assess the performance of a PCR assay for the diagnosis of meningococcal disease after its implementation in a North American setting and to evaluate sensitivity and specificity of the assay for the detection of prevalent bacterial isolates.
  
  
  METHODS
  Laboratory evaluation of the sensitivity and specificity of a PCR assay for Neisseria meningitidis and observational study of a series of cases comparing molecular diagnosis against the criterion standard of conventional laboratory diagnostic tests.
  
  
  METHODS
  A Canadian province with a population of 4 million people.
  
  
  METHODS
  Children and adults presenting with suspected meningococcal disease in British Columbia.
  
  
  METHODS
  The sensitivity and specificity of the PCR assay when compared against standard laboratory methods.
  
  
  RESULTS
  The PCR assay correctly identified all of 38 Canadian isolates of Neisseria meningitidis and correctly assigned the serogroup to each isolate. None of 57 other gram-positive or gram-negative bacteria or yeasts were detected by the PCR assay. In a clinical evaluation, for diagnosis of meningococcal disease, the PCR assay had a sensitivity and specificity of 91% and 76%, respectively, against conventional methods of diagnosis. Use of the PCR assay increased the laboratory confirmation of clinically suspected cases by 36%. During an outbreak, the PCR assay allowed serogroup determination in 3 of 7 cases, aiding in the public health decision to launch an immunization campaign.
  
  
  CONCLUSIONS
  The PCR assay is more sensitive than conventional methods for the diagnosis of meningococcal disease, and enhanced surveillance may help direct the public health response to the changing epidemiology of disease in North America.
authors.affiliation: Division of Infectious and Immunological Diseases, Department of Pediatrics, University of British Columbia, British Columbia's Research Institute for Child and Family Health, Vancouver, Canada. andrew.pollard@paediatrics.ox.ac.uk
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Pollard
authors.forename: Gary
authors.initials: G
authors.lastname: Probe
authors.forename: Colleen
authors.initials: C
authors.lastname: Trombley
authors.forename: Annette
authors.initials: A
authors.lastname: Castell
authors.forename: Sue
authors.initials: S
authors.lastname: Whitehead
authors.forename: J Mark
authors.initials: JM
authors.lastname: Bigham
authors.forename: Sylvie
authors.initials: S
authors.lastname: Champagne
authors.forename: Judy
authors.initials: J
authors.lastname: Isaac-Renton
authors.forename: Rusung
authors.initials: R
authors.lastname: Tan
authors.forename: Malcolm
authors.initials: M
authors.lastname: Guiver
authors.forename: Ray
authors.initials: R
authors.lastname: Borrow
authors.forename: David P
authors.initials: DP
authors.lastname: Speert
authors.forename: Eva
authors.initials: E
authors.lastname: Thomas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001955:British Columbia / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D017931:DNA Primers / Q000737:chemistry; D004269:DNA, Bacterial / Q000097:blood / Q000145:classification; D004196:Disease Outbreaks; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008585:Meningitis, Meningococcal / Q000175:diagnosis* / Q000382:microbiology / Q000401:mortality; D008828:Microbiological Techniques; D009345:Neisseria meningitidis / Q000235:genetics / Q000254:growth & development / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D015996:Survival Rate
chemical_list: D017931:DNA Primers; D004269:DNA, Bacterial