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The RIDASCREEN® Norovirus 3td Generation test is a qualitative enzyme immunoassay (EIA) intended for the detection of selected genogroup I (GI.1, GL.2, GI.3, GI.4, GL.7) and genogroup II (GII.1, GII.2, GII.3, GII.4, GII.5, GII.6, GII.7, GII.8, GII.10, GII.12, GII.13, GII.14, GII.17) norovirus strains in human feces as an aid in investigating the cause of acute gastroenteritis outbreaks. The likelihood of detecting a norovirus outbreak by use of the RIDASCREEN® Norovirus 3td Generation test improves as the number of patients tested during an outbreak increases, as well as when quality of the specimens increases. Preliminary identification of norovirus as the cause of an acute gastroenteritis outbreak by RIDASCREEN® Norovirus 3td Generation testing should be confirmed by reference methods as appropriate, particularly if only a limited number of positive samples are associated with a suspected outbreak. Additional testing of negative samples by other methods should be performed if norovirus is strongly suspected as the cause of an acute gastroenteritis outbreak.

RIDASCREEN® Norovirus 3rd Generation test is a solid phase sandwich-type EIA for the detection of genogroups GI and GII noroviruses in stool samples. Microwell strips are coated with a mixture of GI and GII norovirus specific monoclonal antibodies. An aliquot of fecal suspension is added to the microwell together with biotinylated monoclonal norovirus antibodies. After washing, streptavidin peroxidase conjugate is added. Norovirus antigens that are present in the stool sample are captured in a sandwich complex of the immobilized antibodies, the norovirus antigens and the monoclonal antibodies conjugated with the biotin-streptavidin-peroxidase complex. Unbound streptavidin peroxidase conjugate is removed by washing and a chromogenic colorless substrate solution (hydrogen peroxide/TMB) is added. The substrate is hydrolyzed by any bound peroxidase, changing the chromogen to a blue color. Stopping the reaction with acid converts the blue to a yellow color indicating the presence of norovirus antigens. Test results are read photometrically; intensity significantly above background levels is indicative of the presence of Norovirus antigen in the specimen or control. The RIDASCREEN® Norovirus 3rd Generation test does not identify specific norovirus strains.