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.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world