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Data sheet
| Assay principle | Dengue NS1 Antigen Test is a sandwich solid phase immunochromatographic assay. When sample is added to sample pad, it moves through the conjugate pad and mobilizes gold anti-NS1 conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with anti-NS1 antibody that is coated on the test region. If NS1 is present, the result is the formation of a colored band in the test line region. If there is no NS1 in the sample, the area will remain colorless. The sample continues to move to the control area and forms a pink to purple color, indicating the test is working and the result is valid. Dengue IgG/IgM Antibody Test utilizes the principle of Immuno-chromatography. Mouse anti-human IgM and human IgG antibodies are immobilized on the nitrocellulose membrane respectively, as two individual test lines (IgM line and IgG line) in the test window of the test device. The IgG line in the test window is closer to the sample well and followed by IgM line. As the test sample flows through the membrane within the test device, the colored–Dengue specific recombinant antigen-colloidal gold conjugate complexes with specific antibodies (IgM and/or IgG) of Dengue virus, if present in the sample. This complex moves further on the membrane to the test region where it is captured by the anti-human IgM and/or human IgG antibodies coated on the membrane leading to formation of a colored band, which indicates a positive test results. Absence of this colored band in the test window indicates a negative test result. A built-in control line will always appear in the test window when the test has performed properly, regardless of the presence or absence of anti-Dengue virus antibodies in the specimen. |
| INTENDED USE | Dengue Duo Panel is an in vitro qualitative immunochromato-graphic assay for the rapid detection of Dengue NS1 antigens and anti-dengue IgG/IgM antibodies in human blood, serum and plasma specimens simultaneously. The test results are intended to aid in the diagnosis of dengue infection. |
| Storage and Stability | The sealed pouches in the test kit may be stored between 20-30ºC for the duration of the shelf life as indicated on the pouch. |