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Dengue viruses, transmitted by the mosquito, Aedes aegypti and Aedes albopictus mosquitoes, are widely distributed throughout the tropical and subtropical areas of the world. There are four known distinct serotypes (dengue virus 1, 2, 3 and 4). In children, infection is often subclinical or causes a self-limited febrile disease. However, if the patient is infected a second time with a different serotype, a more severe disease, dengue hemorrhagic fever or dengue shock syndrome, is more likely to occur. Dengue is considered to be the most important arthropod-borne viral disease due to the human morbidity and mortality it causes. Traditionally, the serological diagnosis of an acute dengue virus infection has relied on showing a 4-fold or greater rise in anti-dengue virus antibody between paired acute- and convalescent-phase sera from a patient. The haemagglutination-inhibition test has been the most commonly used serological assay for dengue diagnosis. Rapid and reliable tests for primary and secondary infections of dengue are essential for patient management. Primary Dengue infection is associated with mild to high fever, headache, muscle pain and skin rash. Immune response includes IgM antibodies produced by 5th day of symptoms and persist for 30-60 days. IgGs appear the 14th day and persist for life. Secondary infections often result in high fever and in many cases with haemorrhagic events and circulatory failure. Secondary infections show that IgGs rise within 1-2 days after the onset of symptoms and induce IgM response after 20 days of infection.
The BIONOTE DENGUE IgG&IgM Rapid Test Kit is a chromatographic immunoassay for the qualitative detection of antibodies of Dengue virus (IgG and IgM) in human serum, plasma or whole blood
1) Twenty five (25) BIONOTE DENGUE IgG&IgM Rapid Test Kits
2) One (1) bottle containing 5 ml of assay diluent.
3) Twenty five (25) Capillary tubes
4) One (1) instruction for use
■ Specimen Collection and Preparation
1) The test should be performed using serum, plasma, or whole blood.
2) [Whole blood]
(1) Specimen collection by venipuncture
(2) Specimen collection using a lancet
3) [Plasma] Collect an anticoagulated blood sample using standard
clinical laboratory procedures. Separate plasma by centrifugation.
Plasma samples may be stored refrigerated (2~8°C) for up to 72hours,
for longer storage freeze at or below -20°C in vials with air-tight
44) [Serum] Collect and prepare serum samples using standard clinical laboratory procedures. Serum samples may be stored refrigerated (2~8°C) for up to 72 hours, for longer storage freeze at or below -20°C in vials with air-tight seals.
■ Procedure of the test
1) Allow all kit components and specimen to room temperature prior
to testing. br />
2) Remove the test device from foil pouch, and place it on a flat,
3) Add 10㎕ of serum, plasma, or whole blood into the sample well, using a capillary tube or micropipette into the square sample well(s)
4) Add 3~4 drops(about 90~120㎕) of assay diluent into the diluent well and start the timer.
55) Interpret test results at 15~20 minutes. Do not interpret after 20 minutes.
■ Interpretation of the test
A colored band will appear in the left section of the result window to show that the test is working properly. This band is the control band. The right section of the result window indicates the test result. If another colored band appears in the right section of the result window, it is the test band.
1) Negative result
The presence of one color band ("C" Control line) within the result window indicates a negative result. Retest in 3~5 days if dengue infection is suspected.
2) IgM Positive result
The presence of two color bands ("M" Test line and "C" Control line) within the result window, no matter which band appears first, indicates IgM positive result. This is indicative of a primary dengue infection
3) IgG Positive result
The presence of two color bands ("G" Test line and "C" Control line) within the result window, no matter which band appears first, indicates IgG positive result. This is indicative of a Secondary or past dengue infection
4) Ig M and IgG Positive result
The presence of three color bands (“M”, "G" Test line and "C" Control line) within the result window, no matter which band appears first, indicates IgM and IgG positive result. This is indicative of a late primary or secondary dengue infection
5) Invalid Result
If the control band ("C" Control line) fails to appear within the result window, the result is considered invalid. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen should be re-tested.
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