Dengue IgG/IgM Rapid Test

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

Materials Provided

Materials Required but Not provided

PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.

1. 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. 2. Place the test device on a clean and level surface.

For Serum or Plasma Specimens: 

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 uL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 mL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 uL) and start the timer. See illustration below.

To use a micropipette: Pipette and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer.

3. 3. Wait for the colored line(s) to appear. Read results at 10 minutes.Do not interpret the result after 20 minutes.

4. INTERPRETATION OF RESULTS
   
   
   

   LIMITATIONS OF THE TEST

   1. 1. The Dengue IgG/IgM Rapid Test is for in vitro diagnostic use only. The test should be used for the detection of Dengue antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Dengue antibody concentration can be determined by this qualitative test.
   2. 2. The Dengue IgG/IgM Rapid Testwill only indicate the presence of Dengue antibodies in the specimen and should not be used as the sole criteria for the diagnosis of Dengue.
   3. 3. In the early onset of fever, anti-Dengue IgM concentrations may be below detectable levels. For primary infection, an IgM antibody-capture enzyme-linked immunosorbent assay (MAC-ELISA) showed that 80% of the Dengue patients tested exhibited detectable levels of IgM antibody by the fifth day after infection, and 99% of the patients tested IgM positive by day 10.⁵It is recommended that patients be tested within this time. 
   4. 4. For the secondary infection, a low molar fraction of anti-Dengue IgM and a high molar fraction of IgG that is broadly reactive to flaviviruses characterize the antibodies.⁵ The IgM signal may be faint and the cross reaction in the region of IgG line may appear.
   5. 5. Serological cross-reactivity across the flavivirus group (Dengue 1, 2, 3 & 4, St. Louis encephalitis, West Nile virus, Japanese encephalitis and yellow fever viruses) is common.^6,7,8Positive results should be confirmed by other means.
   6. 6. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
   7. 7. Results from immunosuppressed patients should be interpreted with caution.
   8. 8. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
   9. 9. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of Dengue.
   10. 
   11. 
   12. 
   13.