Dengue IgG/IgM Combo Rapid Test
CTK Biotech, USA Dengue IgG/IgM Combo Rapid 30 Test
The OnSite Dengue IgG/IgM 3.0 Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti–dengue virus (DEN1, 2, 3 and 4) in human serum, plasma or whole blood.
- Utilizes recombinant chimeric dengue virus licensed from the US CDC
- Detects all four dengue serotypes
- IgM detection indicates recent infection
- IgG detection indicates recent or previous infections
- Whole blood specimen alllows testing at the point of care, saving crucial time
- No cross-reaction to 17 common diseases, such HIV, HCV, HBV, CHIK, Malaria, Typhoid
- No interference with common substances
- 24 month shelf life at 2-30 °C storage
Each kit contains :
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- 5 µL Capillary tubes
- Sample diluent (5 mL/bottle)
- One package insert (instruction for use)
TEST PRINCIPLE :
The OnSite Dengue IgG/IgM3.0 Combo Rapid Test is a lateral flow chromatographic immunoassay. The test strip in the cassette consists of: 1) a burgundy colored conjugate pad containing dengue recombinant envelope antigens conjugated with colloidal gold (dengue Ag conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing two test lines (G and M lines) and a control line (C line). The G line is pre-coated with antibodies for the detection of IgG anti-dengue virus, the M line is pre-coated with antibodies for the detection of IgM anti-dengue virus, and the C line is pre-coated with a control line antibody. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action along the cassette. IgG anti-dengue virus, if present in the specimen, will bind to the dengue Ag conjugates. The immunocomplex is then captured by the pre-coated anti-human IgG, forming a burgundy colored G line, indicating an IgG anti-dengue virus positive test result and suggesting a secondary or past infection with dengue virus.
IgM anti-dengue virus, if present in the specimen, will bind to the dengue Ag conjugates. The immunocomplex is then captured by the pre-coated anti-human IgM, forming a burgundy colored M line, indicating an IgM anti-dengue virus positive test result and suggesting either an acute primary or secondary dengue infection. An IgM and IgG positive result indicates a late primary or early secondary acute infection.
Absence of any G, M or T lines suggests a negative result. Each test contains an internal control (C line) which should exhibit a burgundy colored line of the control antibodies regardless of color development on any of the test lines. If the C line does not develop, the test result is invalid and the specimen must be retested with another device.
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