For Laboratory Or Hospital High Accuracy HBsAg Elisa Test Kit

INTRODUCTION

HBsAg ELISA is used for the qualitative determination of Hepatitis B surface antigen (HBsAg) in human serum or plasma. This test is indicated for the screening of blood and blood products to be used for transfusion and an aid for the diagnosis of existing or previous hepatitis B infection

PRINCIPLE OF THE ASSAY

The HBsAg EIA is a solid-phase simultaneous sandwich immunoassay, which employs monoclonal antibodies and polyclonal antibodies specific for HBsAg. Microtiter well are coated with monoclonal antibodies specific for HBsAg. A serum specimen is added to the antibody coated Microtiter wells together with enzyme conjugated polyclonal antibodies. HBsAg, if present, will form an antibody-HBsAg-antibody-enzyme complex. The plate is then washed to remove unbound material. Finally, a solution of substrate is added to the wells and incubated. A blue color will develop in proportion to the amount of HBsAg present in the specimen. The enzyme-substrate reaction can be stopped and the result is visualized by naked eye or read by EIA plate reader for absorbance at the wavelength of 450 nm(450 nm/630 nm) and is proportional to the amount of antibodies present in the specimen.

PRECAUTIONS FOR USERS

• For in-vitro diagnostic use only.
• Do not use kit beyond expiration date.
• Do not mix components from kits with different lot number.
• Avoid microbial contamination of reagents.
• Do not pipet reagent by mouth and no smoking or eating while performing assays.
• Wear gloves during the whole process and avoid reagents or specimen spilling-out.
• Wipe up the spills using 5% hypochlorite solution.
• Decontaminate all liquids or solid wastes before deposing.

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