Dengue IgG/IgM And NS1 Combo Rapid Test, Characterized By A Sudden Onset Of

Product Specification

Dengue IgG/IgM And NS1 Combo Rapid Test, Characterized By A Sudden Onset Of Fever

Description: 

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 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of NS1 antigen, IgG and IgM antibodies of dengue virus in human whole blood, serum or plasma.

How to use? 

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within 1 hour.

2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
For IgG/IgM:
To use a dropper: Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5μl), and transfer the specimen to the specimen well (S) of the test cassette, then add 3 drops of buffer (approximately 120μl) to the buffer well (B) and start the timer. Avoid trapping air bubbles in the specimen well.

To use a micropipette: Pipette and dispense 5 μl of serum or plasma to the specimen well (S) of the test cassette, then add 3 drops of buffer (approximately 120μl) to the buffer well (B) and start the timer.

For NS1:
 Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75μl) to the specimen well (S), and start the timer. See illustration below.

 For Whole Blood(Venipuncture/Fingerstick) specimen:
For IgG/IgM:
To use a dropper: Hold the dropper vertically, draw the specimen up to about 1cm above the fill line, and transfer 1 drop of whole blood (approximately 10μl) to the specimen well (S) of the test cassettes, then add 3 drops of buffer (approximately 120μl) to the buffer well (B) and start the timer. See illustration below.

To use a micropipette: Pipette and dispense 10μl of whole blood to the specimen well (s) of the test cassette, then add 3 drops of buffer (approximately 120μl) to the buffer well (B) and start the timer. See illustration below.

For NS1:
To use a dropper: Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75μL) to the specimen well (s), then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.
 

To use a capillary tube: Fill the capillary tube and transfer approximately 75μL of fingerstick whole blood specimen to the specimen well(s) of test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.

3. Read the results at 10 minutes, do not interpret the results after 20 minutes.
Note: It is suggested not to use the buffer beyond 6 months after opening the vial.

INTERPRETATION OF RESULTS
(Please refer to the illustration above)

NS1 POSITIVE: * Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).

IgG and IgM POSITIVE:* Three colored 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 indicated end stage of primary Dengue infection and early stage of secondary Dengue infection.

IgG POSITIVE:* Two colored 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 colored 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 colored line appears in the control region (C). No 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.

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