Dengue IgG/IgM Rapid Test

Intended Use

Dengue IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) 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.

What is Dengue hemorrhagic fever?

Dengue viruses are spread to people through the bite of an infected Aedes species mosquito. Dengue is common in more than 100 countries around the world. 40% of the world's population, about 3 billion people, live in areas with a risk of dengue.

Materials

● Individually packed test devices

● Package insert

● Disposable pipettes

● Buffer

Procedure

Allow Dengue IgG/IgM Rapid 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.

For Serum or Plasma Specimens:

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 µL), and transfer all the specimen to the specimen well (S) of the test device, then add 2 drops of buffer and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well. (S).

For Whole Blood (Venipuncture / Fingerstick) Specimens:

Using the provided disposable pipette, draw the specimen above the fill line (avoid the specimen entering the bubble of disposable pipette) and transfer one drop of the specimen(approximately 10 µL) into the specimen well of the test device, then add 2 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 at15 minutes. Do not interpret the result after 30 minutes.

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