European multicenter evaluation of commercial enzyme immunoassays for detecting norovirus antigen in fecal samples

Clin Vaccine Immunol. 2007 Oct;14(10):1349-55. doi: 10.1128/CVI.00214-07. Epub 2007 Aug 22.

Abstract

A total of 2,254 fecal samples were tested in a European multicenter evaluation of commercially available norovirus antigen detection assays. Two commercial enzyme immunoassays, IDEIA Norovirus (Oxoid; Thermo Fisher Scientific, Ely, United Kingdom) and RIDASCREEN Norovirus (R-Biopharm, Darmstadt, Germany), were included in the evaluation, and their performance was compared with the results of reverse transcription-PCR (RT-PCR). Included in the evaluation were samples collected in sporadic cases of gastroenteritis, samples from outbreaks in which two or more samples were collected, well-characterized samples representing genotypes currently cocirculating within Europe, and samples collected from patients with gastroenteritis caused by a pathogen other than norovirus. The sensitivities and specificities of the IDEIA Norovirus and RIDASCREEN Norovirus assays were 58.93 and 43.81% and 93.91 and 96.37%, respectively, compared with RT-PCR. The sensitivities of both assays for outbreak investigations improved when six or more samples from an outbreak were examined. The IDEIA Norovirus assay exhibited reactivity to a broader range of norovirus genotypes than the RIDASCREEN Norovirus assay, which showed genotype-dependent sensitivities. The results indicate that, if used, these assays should serve as screening assays and the results should be confirmed by RT-PCR.

Publication types

  • Comparative Study
  • Evaluation Study
  • Multicenter Study
  • Validation Study

MeSH terms

  • Antigens, Viral / analysis*
  • Antigens, Viral / immunology
  • Caliciviridae Infections / diagnosis
  • Caliciviridae Infections / immunology
  • Europe
  • Feces / virology*
  • Gastroenteritis / diagnosis
  • Gastroenteritis / immunology
  • Humans
  • Immunoenzyme Techniques* / standards
  • Norovirus / immunology*
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity

Substances

  • Antigens, Viral
  • Reagent Kits, Diagnostic