DENGUE NS1-IgM/IgG Whole Blood/Serum INSTRUCTION Test Kit

INTENDED USE

The Dengue Ag NS1-IgM/IgG rapid test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti– dengue virus, IgM anti-dengue virus and dengue antigen (Dengue Ag) in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with dengue virus. Any reactive specimen with the Dengue Ag NS1-IgM/IgG rapid test must be confirmed with alternative testing method(s).

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STORAGE AND STABILITY

All reagents are ready to use as supplied. Store unused test device unopened, preferably at 2°C-30°C. Do not expose the kit over 40°C. Do not freeze the kit. The positive and negative controls should be kept at 2°C-8°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch if it is stored at 2°C-30°C.

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