SARS-CoV-2 Virus IgM Antibody Detection Kit (ELISA)

INTENDED USE

This kit is used for the qualitative detection of SARS-CoV-2 virus-specific IgM antibodies in human serum or plasma in vitro.

Testing method

Reagent preparation All reagents should be kept in advance at room temperature (10-30°C) for 30 minutes and the surface moisture should be confirmed to be dry before use. l Coated plate: Ready to use directly. The outer aluminum foil bag must be opened after the plate stays at room temperature to prevent the strip from absorbing water vapor in the air. Please return the remaining strips to the aluminum foil bag (or plastic bag) containing the desiccant for sealing immediately. l Positive Control and Negative control: They can be use directly, mixed before use. l Enzyme solution: It can be used directly, mix before use. l 20X concentrated washing buffer: Use a clean pipette to draw the required amount from the bottle and dilute it with purified water 1:19 to prepare a washing solution for later use. For example: Take 1mL of concentrated washing buffer and dilute with 19mL purified water. The diluted washing buffer is stable for up to one week at temperature range 2°C-8°C. If crystal appear in the concentrated washing buffer, the solution should be heated at 37°C, to be fully dissolved and mixed before dilution. l Substrate A, B: It can be used directly. As the substrate is light sensitive, cap the bottle immediately after use and store it back to avoid light exposure. l Stop buffer: It can be used directly. l Sealing glue: It can be used directly and should be used only once to avoid cross contamination

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