Dengue IgG and IgM and NS1 Combo Test

Intended Use

Dengue IgG and IgM and NS1 Combo Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Dengue virus (DENV) NS1 antigen, anti-DENV IgM and anti-Dengue IgG in human whole blood, serum, or plasma as an aid in the diagnosis of Dengue infections.

High risk areas

Materials

● Individually packed test devices

● 5-uLdisposable pipettes for Dengue IgG/IgM

● Package insert

● Buffer

● 25-uLdisposable pipettes for Dengue NS1

Procedure

Allow Dengue IgG and IgM and NS1 Combo 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. Remove the test device from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface. Label the test with patient or control identification.

For Serum or Plasma Specimens:

a) Using the provided 25-uL disposable pipette, transfer 1 drop of serum or plasma to the specimen well (S1), and add 1 drop of buffer, then start the timer.

b) Using the provided 5-uL disposable pipette, draw the specimen up to the Fill Line, and transfer all the serum/plasma (appr. 5 uL), onto the specimen well (S2) of the test device, then add 3 drops of buffer and start the timer.

For Whole Blood Specimens:

a) Using the provided 25-μL disposable pipette, transfer 2 drops of whole blood onto the specimen well (S1), and add 1 drop of buffer, then start the timer.

b) Using the provided 5-uL disposable pipette, draw the specimen 0.5-1cm above the Fill Line, and transfer 1 drop of whole blood (appr. 10 µL) onto the specimen well (S2) of the test device, then add 3 drops of buffer and start the timer.

Note: Specimens can also be applied using a micropipette.

3. Wait for the colored line(s) to appear. Read results at 10 minutes.

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