High Accuracy DENGUE IgM/IgG Whole blood/Serum Elisa Test Kit

INTENDED USE

The Dengue IgG/Ig Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–dengue virus and IgM anti-dengue virus in human serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with dengue viruses. Any reactive specimen with the Dengue IgG/IgM^3.0 Rapid Test must be confirmed with alternative testing method(s).

Materials provided

1.Each kit contains 25 or 30 test devices, each sealed in a foil pouch with two items inside:

a. One cassette device.

b. One desiccant.

2. 25 or 30 x 5 µL mini droppers.

3. Sample Diluent (2 bottles, 5 mL).

4.One package insert (instruction for use).

PRECAUTIONS

1.For in vitro diagnostic use and professional use only.

2.Read the package insert instruction before use the kit.

3.Do not use beyond the expiration date which appears on the package label.

4.Do not open the sealed pouch, unless ready to conduct the assay.

5.Bring all reagents to room temperature (15°C-30°C) before use.

6.Do not use the components in any other type of test kit as a substitute for the components in this kit.

7.Haemolized blood may be used for the testing, but do not take precipitants.

8.Wear protective clothing and disposable gloves while assaying samples. Wash hands thoroughly after performing the test.

9.Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving them for at least one hour. Alternatively, they can be treated with 0.5 to 1% solution of sodium hypochlorite for one hour before disposal.

10.Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.