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A rapid test for a qualitative test for the detection of NS1 antigen, IgG and IgM antibodies of dengue virus CE certified
The Dengue Combo Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of NS1 antigen and IgG and IgM antibodies of Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of Dengue infections.
Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It is widely distributed throughout the tropical and subtropical areas of the world,1 and causes up to 100 million infections annually.2 Classic Dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia and rash.
Primary Dengue infection causes IgM antibodies to increase to a detectable level in 3 to 5 days after the onset of fever. IgM antibodies generally persist for 30 to 90 days.3 Most Dengue patients in endemic regions have secondary infections,4 resulting in high levels of specific IgG antibodies prior to or simultaneous with IgM response.5 Therefore, the detection of specific anti-Dengue IgM and IgG antibodies can also help to distinguish between primary and secondary infections.
NS1 is one of 7 Dengue Virus non-structural proteins which are thought to be involved in viral replication. NS1 exists as a monomer in its immature form but is rapidly processed in the endoplasmic reticulum to form a stable dimer. A small amount of NS1 remains associated with intracellular organelles where it is thought to be involved in viral replication. The rest of NS1 is found either associated with the plasma membrane or secreted as a soluble hexadimer. NS1 is essential for viral viability but its precise biological function is unknown. Antibodies raised in response to NS1 in viral infection can cross react with cell surface antigens on epithelial cells and platelets and this has been implicated in the development of Dengue Hemorrhagic fever.
The Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of Dengue antigen coated colored particles for the detection of IgG and IgM Dengue antibodies in human whole blood, serum, or plasma.
The Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of Dengue antibodies coated colored particles for the detection of Dengue NS1 antigen in human whole blood, serum, or plasma.
How to use?
30°C) prior to testing.
· Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75μl) to the specimen area, and start the timer. See illustration below.
To use a dropper: Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 μl), and transfer the specimen to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40µl) and start the timer. Avoid trapping air bubbles in the specimen well.
To use a micropipette: Pipette and dispense 5 µl of whole blood to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40 µl) and start the timer.
· To use a micropipette: Pipette and dispense 10 µl of whole blood to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40 µl) and start the timer. See illustration below.
Read the results at 10 minutes, do not interpret the results after 20 minutes
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NS1 POSITIVE: * Two distinct colored lines appear. One color line should be in the control region (C) and another color line should be in the test region (T).
IgG and IgM POSITIVE:* Three lines appear. One colored line should be in the control line region (C), and two colored lines should appear in IgG test line region and IgM test line region. The color intensities of the lines do not have to match. The result is positive for IgG&IgM antibodies and is indicative of secondary Dengue infection.
IgG POSITIVE:* Two lines appear. One colored line should be in the control line region (C),and a colored line appears in IgG test line region. The result is positive for Dengue virus specific-IgG and is probably indicative of secondary Dengue infection.
IgM POSITIVE:* Two lines appear. One colored line should be in the control line region (C),and a colored line appears in IgM test line region. The result is positive for Dengue virus specific-IgM antibodies and is indicative of primary Dengue infection.
*NOTE: The intensity of the color in the test line region (NS1 and/or IgG and/or IgM) will vary depending on the concentration of Dengue NS1 antigen and/or IgG and/or IgG present in the specimen. Therefore, any shade of red in the test region should be considered positive.
NEGATIVE: One color line appears in the control region (C). No apparent red or pink line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Internal procedural controls are included in the test. A color line appearing in the control region (C) is an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.