Key result
The RIDASCREEN 3rd Generation EIA kit demonstrated a low sensitivity of 35% and a specificity of 100% for detecting norovirus in fecal samples from mostly asymptomatic children compared to RT-PCR.
Why the study?
What is the sensitivity and specificity of a third-generation EIA kit for detecting norovirus in fecal samples from mostly asymptomatic children compared to RT-PCR?
Cross-Sectional (n=60)
No
What is the sensitivity and specificity of a third-generation EIA kit for detecting norovirus in fecal samples from mostly asymptomatic children compared to RT-PCR?
The third-generation EIA kit has poor sensitivity (35%) for detecting norovirus in asymptomatic children, suggesting it should not replace molecular assays like RT-PCR in this population.
Answers are grounded in this paper and cite their sources.
Caution against EIA reliance for norovirus in asymptomatic children; leaves open need for sensitive antigen assays in pediatric screening.
Norovirus is the leading cause of non-bacterial acute gastroenteritis outbreaks worldwide. Recently, third generation Enzyme Immunoassay (EIA) commercial kits have been developed, and controversial results have been obtained by different studies regarding the sensitivity and specificity of these assays. Therefore, the aim of this study was to test 60 fecal samples, previously tested as positive by RT-PCR for caliciviruses (40 norovirus-positive and 20 sapovirus-positive samples), for qualitative determination of genogroup I and II noroviruses by a commercial EIA kit (RIDASCREEN® Norovirus (C1401) 3rd Generation, R-Biopharm, Darmstadt, Germany). The samples were obtained from 30 children aged less than five years, mostly asymptomatic, who attend a day-care center in Goiânia, Goiás, Brazil. The results conferred a positivity rate for NoV of 35% and a specificity rate of 100% for the EIA, when compared to the RT-PCR. The test also failed to detect samples that were positive for GI.1 and GI.4 norovirus. The presumably lower viral load of asymptomatic children might be related to the poor sensitivity. Our results reinforce the notion thatscreening of samples by molecular assays, especially of samples that might have a low number of viral particles such as those obtained from asymptomatic patients, should not be replaced by the use of EIA kits.
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Santos et al. (2014) conducted a cross-sectional in Asymptomatic norovirus infection (n=60). RIDASCREEN Norovirus 3rd Generation EIA kit vs. RT-PCR was evaluated on Sensitivity for norovirus detection compared to RT-PCR. The RIDASCREEN 3rd Generation EIA kit demonstrated a low sensitivity of 35% and a specificity of 100% for detecting norovirus in fecal samples from mostly asymptomatic children compared to RT-PCR.
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