TEST PROCEDURE:

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop of whole blood to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15 - 30°C. If your room temperature is significantly lower than 15 °C, then the interpreting time should be properly increased to 30 minutes.
INTERPRETATION OF RESULTS:

INTENDEDUSE:
IgG Positive:
The control line and IgG line (T1) are visible in the result window. The test is positive for IgG antibodies. This indicates a past dengue infection.
IgM Positive:
The control line and IgM line (T2) are visible in the result window. The test is positive for IgM antibodies. This indicates a primary dengue infection.
IgM and IgG Positive:
The control line, IgM (T2)and IgG (T1) lines are visible in the result window. The test is positive for IgM and IgG antibodies. This indicates a secondary dengue infection.
Negative:
The control line is the only line visible in the result window. No IgG or IgM antibodies have been detected. The result does not exclude dengue infection. If symptoms persist, a new specimen should be drawn from the patient in 3-5 days and then should be retested (see the limitations section).
Invalid:
If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.
SPECIFICATION: 

Description	Specimen	Format	Catalog No.	Sensitivity	Package Size	Strip Width	Certificate
Dengue lgG/gM Rapid test	Serum/Plasma	Cassette	B30-20	94.4%	25 Tests	4.0 mm	CE
	Whole Blood	Cassette	B30-21		25 Tests	4.0 mm
			B30-22		1 Test	4.0 mm