INTENDED USE

The Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of both dengue virus NS1 Ag and IgM& IgG antibodies to dengue virus (DV) in human whole blood, serum or plasma, and serves as an aid in the diagnosis of Dengue infections. It only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and using more specific alternative diagnosis methods to make final decision. This test is a screening test, and all positives must be confirmed using an alternate test. The test is intended for healthcare professional use only.

PRODUCT PARAMETERS

﹒CE-marked

﹒Sensitivity: NS1 Ag: 97.44%; Anti-Dengue (IgG & IgM): 95.60%

﹒Specificity: NS1 Ag: 99.14%; Anti-Dengue (IgG & IgM): 99.36%

﹒Specimen: whole blood, serum or plasma 

﹒Test time: 15-20 minutes

﹒Storage temperature: 2-30℃ 

﹒Shelf life: 24 months 

ORDERING INFORMATION