Key result
IDEIA and RIDASCREEN norovirus assays yield low sensitivity but high specificity versus RT-PCR.
Why the study?
The performance of commercial enzyme immunoassays for detecting norovirus antigen in fecal samples compared with RT-PCR was evaluated to understand their diagnostic accuracy.
Do commercial enzyme immunoassays accurately detect norovirus antigen in fecal samples compared to RT-PCR?
Observational (n=2,254)
Yes
Do commercial enzyme immunoassays accurately detect norovirus antigen in fecal samples compared to RT-PCR?
Commercial enzyme immunoassays for norovirus have low sensitivity compared to RT-PCR and should only be used as screening tools requiring RT-PCR confirmation.
Answers are grounded in this paper and cite their sources.
Antigen EIAs show modest sensitivity for norovirus detection; leaves open optimal screening role pending improved assays or prospective validation.
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.
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Gray et al. (2007) conducted an observational in Gastroenteritis (n=2,254). Commercial enzyme immunoassays (IDEIA Norovirus and RIDASCREEN Norovirus) vs. RT-PCR was evaluated on Sensitivity and specificity for norovirus antigen detection. The IDEIA and RIDASCREEN Norovirus assays showed low sensitivities but high specificities compared with RT-PCR for detecting norovirus in fecal samples.
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