Dengue Rapid Tests
One Step Dengue IgG & IgM Test
(Serum / Whole Blood)
For In vitro Diagnostic Use Only
The Dengue IgM and IgG Combo Rapid Test is a qualitative test for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood. This test is for in-vitro diagnostic use only.
Dengue virus, a virus belonging to the Flavavirus group of viruses, is one of the most significant mosquito-born diseases in the world in terms of morbidity and mortality. Transmitted principally by the mosquito types Aedes aegypti and Aedes albopictus, the virus is found commonly throughout the tropic and subtropic regions of the world. There are four known serotypes of dengue. Symptoms of dengue fever include high fever, headache, muscle pain and skin rash. The complications often associated with this infection are dengue hemorrhagic fever or dengue shock syndrome. The immune response to this virus includes the production of IgM antibodies by the 5th day of symptoms, which remain in the circulatory system for 30-60 days. IgG antibodies appear by the 14th day of infection and persist for life. A secondary infection often results in high fever and, in many cases, initiates hemorrhagic events and circulatory failure. A secondary infection also induces an IgM antibody response after 20 days of infection and IgG antibodies rise within 1-2 days after the onset of symptoms. Therefore, patients with secondary infections will have a positive IgG result, usually with a positive IgM result as well. Thus, the use of a reliable and sensitive rapid serological test that can simultaneously detect the presence of anti-dengue IgG and IgM antibodies is of great clinical utility. By using a mixture of highly purified dengue proteins, the test is able to detect all 4 Dengue serotypes.
1 Dengue test device
2 Assay diluent
3 Instruction for use
• Remove the appropriate number of Dengue Combo Test Device pouches from the kit box.
• Tear open the foil pouch and remove the device. Lay the test device on a clean, flat work surface.
• Add 1 drop (approximately 30ul) of whole blood or 2-3 drops serum /plasma into sample well with a pipet.
• Then add 1-2 drops (approximately 50-90ul) of wash buffer provided in the dropper bottle holding the bottle vertically from the sample well.
Negative results must be confirmed after 20 minutes. Do not read results after 30 minutes.
INTERPRETATION OF THE RESULTS:
The control line and IgG line are visible on the test stripe. The test is positive for IgG antibodies. This is indicative of a past dengue infection.
The control line and IgM line are visible on the test strip. The test is positive for IgM antibodies. This is indicative of a primary dengue infection.
IgM and IgG Positive
The control line, IgM and IgG lines are visible on the test strip. The test is positive for IgM and IgG antibodies. This is indicative of a secondary dengue infection.
Negative Test Result
The control line is the only line visible in the test device window. No IgG or IgM antibodies were detected. The result does not exclude dengue infection. If symptoms persist, a new sample should be drawn from the patient in 3-5 days and then should be retested (see the limitations section).
Invalid Test Result
If the control line does not appear in the test device window, the test results are INVALID regardless of the presence or absence of line in the test region of the device window. Repeat the test using a new device.