Intended Use:

Test for detection of both NS1 antigen and IgG/IgM antibody against Dengue virus in serum and plasma.

Introduction:

The NS1 antigen is expected to be detected 1 day after the onset of fever and persist upto 9 days in both primary and secondary dengue infection. But the detection of NS1 is inhibited, if anti- NS1 is produced. Primary dengue is characterized by the presence of detectable IgM 3-4 days after the onset infection. Secondary dengue is characterized by the elevation of IgG 1-2 days after the onset infection and in majority of cases this is generally accompanied by an elevation of IgM.

Method Principal:

The Dengue NS1 Antigen Test Device (Serum/ Plasma/Whole Blood) is a qualitative test for the detection of NS1 antigen to dengue virus in human serum or plasma. Only serum and plasma samples may be used with this test.
For NS1 Antigen: First a specimen is dispensed buffer; the Gold antibody conjugate will bind to Dengue antigen in the specimen sample which in turn will bind with Anti-Dengue NS1 coated on the membrane. As the reagent moves across the membrane, the Dengue NS1 antibody on the membrane will bind the antibody-antigen complex causing pale or dark pink line to form at the test line region of the test membrane. The intensity of the lines will vary depending upon the amount of antigen present in the sample. The appearance of pink line in the test region should be considered as positive result.
For IgG/IgM Antibodies: First a specimen is dispensed with sample buffer, the Gold antigen conjugate will bind to anti- Dengue IgG and IgM antibodies in the specimen sample which in turn will bind with Anti-Human IgG and Anti-Human IgM coated on the membrane as two separate lines in the test region as the reagent move across the membrane. The anti-Human antibodies on the membrane will bind the IgG or IgM antigen complex at the relevant IgG and or IgM test lines causing pale or dark pink lines to form at the IgG or IgM region of the test membrane. The intensity of the lines will vary depending upon the amount of antibody present in the sample.