Customization: | Available |
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Type: | Detection Card |
Type1: | Ivd Reagent |
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INTENDED USE
Norovirus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Genegroup 1 and Genegroup 2 noroviruses antigens in human stool specimen.The test results are intended to aid in the diagnosis of Norovirus infection for children and adults with the symptoms of suspected gastroenteritis caused by the Norovirus.
MATERIALS
Materials Provided
1. Individually packed test devices
2. Specimen collection tubes with extraction buffer(1 ml)
3.Disposable dropper
4. Package insert
Materials Required but Not provided
1. Specimen collection containers
2. Timer
TEST PROCEDURE
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
PERFORMANCE CHARACTERISTICS
Table: Norovirus Antigen Rapid Test vs. RT-PCR
Relative Sensitivity: 93.55% (95%CI: 88.46%~96.86%)
Relative Specificity: 99.25% (95%CI: 97.33%~99.91%)
Accuracy: 97.16% (95%CI: 95.10%~98.53%)