title: Evaluation of 15 commercial enzyme immunoassays for the detection of rubella-specific IgM.
abstract: BACKGROUND
  Detection of rubella-specific IgM is a critical investigation in the diagnosis of recent or congenital rubella for which many commercial enzyme immunoassays (EIAs) are now available.
  
  
  OBJECTIVE
  To evaluate 15 commercially-available EIA kits for the detection of rubella-specific IgM.
  
  
  METHODS
  A panel of 229 sera was established comprising 72 sera from cases of primary rubella, re-infection, congenital rubella and primary immunization in which rubella-specific IgM had been detected by M-antibody capture radioimmunoassay (MACRIA); 80 sera, negative by MACRIA and no evidence of recent illness; 77 sera from recent illness with a number of other microbial agents, sera containing rheumatoid factor, and sera previously shown to give non-specific reactivity by MACRIA. These sera were tested in 15 commercial EIA kits for rubella-specific IgM according to the manufacturers' instructions. Sensitivity and specificity for each assay was established.
  
  
  RESULTS
  Specificities ranged from 82-98%, improving to 88-100% if the previously established non-specific reactive sera were excluded. Sensitivities ranged from 63-92%. Although only two sera from congenital rubella were tested, for one serum only four assays detected specific IgM.
  
  
  CONCLUSIONS
  Some commercial EIAs for rubella-specific IgM now give an acceptable balance of sensitivity and specificity, but all assays may give reactivity with occasional sera where there is no supporting evidence for recent primary rubella or rubella reinfection.
authors.affiliation: Department of Virology, Public Health Laboratory, Royal Preston Hospital, P.O. Box 202, Preston PR2 4HG, UK.
authors.forename: P
authors.initials: P
authors.lastname: Hudson
authors.forename: P
authors.initials: P
authors.lastname: Morgan-Capner