Intended Use
Dengue Day 1 Test is a rapid solid phase immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen and differential detection of IgM and IgG antibodies to Dengue virus in Human serum/plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of Dengue infection & presumptive diagnosis between primary and secondary Dengue infection.
Salient Features
- First line testing kit for detecting dengue infection from day 1 using NS1 Antigen & differential detection of IgM & IgG Antibodies.
- Diagnosis of both Primary & Secondary Infection.
- Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4).
- Highly Sensitive & Highly Specific
- Long shelf life: 30 months at 2-30°C.
- Convenient pack sizes: 10 Tests, 30 Tests & 50 Tests.
Principle
Dengue Day 1 test kit consists of two devices: one device for detection of Dengue NS1 antigen and second device for the differential detection of Dengue IgM/IgG antibodies in Human serum/plasma. Dengue NS1 Antigen device contains two lines; ‘C’ (Control line) & “T” (Dengue NS1 Antigen test line). Test line is coated with anti-dengue NS1 Ag. When a sample is added to the device, Dengue NS1 antigen if present in the sample will bind to the anti-dengue NS1 gold colloidal conjugate making antigen antibodies complex. This complex migrates along the membrane to the test region and forms the visible pink line at “T” as antibody-antigen-antibody gold colloid forms. Dengue IgM/IgG test device contains three lines; “C” (Control line), “M”(IgM test line) & “G”(IgG test line).IgM test line is coated with anti-human IgM and IgG test line is coated with anti-human IgG.When a sample is added to the device, IgG and IgM antibodies in the sample react with anti-human IgM or IgG antibodies coated on the membrane respectively. Colloidal gold complexes containing dengue 1-4 antigens is captured by the bound anti-dengue IgM or IgG on respective test bands located in the test window causing a pale to dark red band to form at the IgG or IgM region of the test device window.
