title: Evaluation of rubella IgM enzyme immunoassays.
abstract: BACKGROUND
  Rubella virus generally causes a mild fever, rash illness similar in clinical presentation to infections by other viruses including measles and parvovirus B19. Rubella infections in pregnant women in the first trimester carry a high risk of congenital rubella syndrome (CRS) which can result in severe congenital defects in the infants. The goal of rubella immunization programs is therefore to eliminate CRS. The primary test for the laboratory confirmation of rubella is IgM serology. It is therefore important to evaluate currently available commercial rubella IgM immunoassays to ensure high quality rubella diagnostic testing.
  
  
  METHODS
  In this study, we compared the performance of seven commercial rubella IgM enzyme immunoassays (EIA) (Meddens, Denka Seiken, Behring, Wampole, Captia, Sigma and Abbott Axsym) using well-defined panels of sera from rubella and non-rubella/rash-illness cases.
  
  
  RESULTS
  The Meddens, Denka Seiken, Behring and Wampole rubella IgM EIAs all performed similarly for sensitivity (range of 74.1-76.8%) and specificity (range of 93.9-96.1%). Relative to the other assays, the Axsym had a higher sensitivity (78.9%) but lower specificity (86.5%). The Captia assay had the lowest overall sensitivity (66.4%), while the Sigma assay had a lower specificity (85.6%) in relation to the other assays.
  
  
  CONCLUSIONS
  In conclusion, the Meddens, Denka Seiken, Behring and Wampole rubella IgM EIAs are comparable in their overall performance with respect to sensitivity and specificity.
authors.affiliation: National Microbiology Laboratory, Health Canada, Winnipeg, Manitoba, Canada. graham_tipples@hc-sc.gc.ca
authors.forename: Graham A
authors.initials: GA
authors.lastname: Tipples
authors.forename: Rasool
authors.initials: R
authors.lastname: Hamkar
authors.forename: Talat
authors.initials: T
authors.lastname: Mohktari-Azad
authors.forename: Michael
authors.initials: M
authors.lastname: Gray
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ball
authors.forename: Carol
authors.initials: C
authors.lastname: Head
authors.forename: Samuel
authors.initials: S
authors.lastname: Ratnam
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D007075:Immunoglobulin M / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D012409:Rubella / Q000175:diagnosis*; D012412:Rubella virus / Q000276:immunology; D012680:Sensitivity and Specificity
chemical_list: D000914:Antibodies, Viral; D007075:Immunoglobulin M; D011933:Reagent Kits, Diagnostic