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Clinical and Vaccine Immunology, October 2007, p. 1349-1355, Vol. 14, No. 10
1071-412X/07/$08.00+0     doi:10.1128/CVI.00214-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

European Multicenter Evaluation of Commercial Enzyme Immunoassays for Detecting Norovirus Antigen in Fecal Samples

Enteric Virus Unit, Virus Reference Department, Centre for Infections, Health Protection Agency, 61 Colindale Ave., London NW9 5HT, United Kingdom,¹ Laboratoire de Virologie, CHU du Brocage, 21034 Dijon Cedex, France,² Dipartimento di Sanitá Alimentare e Animale, Instituto Superiore di Sanitá, V. le Regina Elena 299, 00161 Rome, Italy,³ Diagnostic Laboratory for Infectious Diseases and Perinatal Screening, National Institute for Public Health and the Environment, Antonie van Leeuwenhoeklaan 9, P.O. Box 1, 3720BA Bilthoven, The Netherlands,⁴ Centro Nacional de Microbiologia Instituto de Salud Carlos III, Madrid, Spain,⁵ Department for Molecular Epidemiology of Viral Pathogens, Robert Koch-Institut, Berlin, Germany⁶

Received 22 May 2007/ Returned for modification 16 July 2007/ Accepted 15 August 2007

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.

Published ahead of print on 22 August 2007.