Packing specification：25T 

Intended use：

The EUGENE® Dengue Ns1+IgG/IgM Rapid Test is a lateral flow immunochromatographic assay for the rapid qualitative detection and differentiation of dengue virus NS1 antigen, IgG and IgM antibodies to dengue virus in human wole blood, serum or plasma. It is intended for professional use to aid in the diagnosis for dengue virus infection. It provides only a preliminary test result. Therefore, isolation of virus, antigen detection in fixed tissues, RT-PCR and serological test like haemagglutination-inhibition test, more specific alternative diagnosis method must be used in order to obtain a confirmation of dengue virus infection.

TEST PROCEDURE ：

1.Remove the test device from the foil pouch and place it on a clean and flat surface. Be sure to label the device with specimen’s ID number.

Dengue IgG/IgM Rapid Test:

For serum or plasma specimens:

Use the provided dropper or a micropipette to add 10ul of serum specimen into the sample well of the IgG/IgM test. Then add 2 drops of assay buffer (about 80ul) to the same sample well. And start the timer.

For whole blood (Venipuncture or Fingerstick) specimens:

To use a micropipette: Pipette and dispense 10ul of whole blood to the specimen well of the IgG/IgM test, the add 2 drops of assay buffer (about 80ul) to the same sample well. And start the timer.

To use a dropper: Hold the dropper vertically to draw the specimen and transfer 1 drop (10ul) of whole blood into the sample well of the IgG/IgM test, then add 2 drops of assay buffer (about 80ul) to the same sample well. And start the timer.

Dengue Ns1 Ag Rapid Test:

For serum or plasma specimen: Use the provided dropper or a micropipette to add 60ul of serum specimen into the sample well of the Ns1 Ag test. Then add 1 drop of assay buffer (about 40ul) to the same sample well. And start the timer.

For whole blood specimen:

To use a micropipette: Pipette and dispense 60ul of whole blood to the specimen well of the Ns1 Ag test, the add 1 drop of assay buffer (about 40ul) to the same sample well. And start the timer.

To use a dropper: Hold the dropper vertically to draw the specimen and transfer 2 drops (60ul) of whole blood into the sample well of the Ns1 Ag test, then add 1 drop of assay buffer (about 40ul) to the same sample well. And start the timer.

2.Interpret test results at 15 minutes. Don’t read result after 20 minutes.

 INTERPRETATION OF RESULTS:

Possible setting for the test: Home, workplace, physician’s office or clinical labs

Storage conditions and expiration date：

1. The original package shall be stored at 4℃ ~ 30℃, and shall not be frozen. The validity period is 24 months from the date of verification and qualification.

2. The test paper should be used within 1 hour after the original aluminum foil bag is opened.