INTENDED USE
The Dengue IgG/IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.
Materials Provided
- Individually packed test devices
- Disposable pipettes
|
|
Materials Required but Not provided
- Specimen collection container
- Centrifuge
- Micropipette
|
|
TEST PROCEDURE
Allow the test device, specimen, buffer, and/or controls to reach room temperature (10 - 30°C) prior to testing.
1. Remove the test device from the foil pouch and use it within one hour.
2. Place the test device on a clean and level surface.
To use the disposable pipette: Hold the disposable pipette vertically, draw the specimen and deliver 1 drop (approximately 10 μL) of the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 μL) and start the timer.
To use a micropipette: Pipette and dispense 10 μL of the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 μL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
IgG Positive:* The colored line in the control line region (C) appears, and a colored line appears in test line region G The result is positive for Dengue virus specific-IgG and is probably indicative of secondary Dengue infection.
IgM Positive:* The colored line in the control line region (C) appears, and a colored line appears in test line region M. The result is positive for Dengue virus specific-IgM antibodies and is indicative of primary Dengue infection.
IgG and IgM Positive:* The colored line in the control line region (C) appears, and two colored lines should appear in test line regions G and M. 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.
NOTE: The intensity of the color in the test line region(s) (G and/or M) will vary depending on the concentration of Dengue antibodies in the specimen. Therefore, any shade of color in the test line region(s) (G and/or M) should be considered positive.
Negative: Only one colored band appears in the control region (C). No line appears in test line regions G or M.
INVALID: No Control line (C) appears.
Audited Supplier 
){kind=link}