This kit is based on the principle of highly specific
antibody-antigen reaction and colloidal gold labeling
immunochromatographic analysis technology. The reagent contains
COVID-19 monoclonal antibody prefixed in the test area (T) on the
membrane and the COVID-19 monoclonal antibody coated on the label
pad-colloidal gold mixture. The sample is dripped into the sample
well and reacts with the COVID-19 monoclonal antibody which is
bound to the pre-coated colloidal gold particles when testing. Then
the mixture is chromatographed upwards with capillary effects. If
it is positive, the antibody labeled by colloidal gold particles
will first bind to the COVID-19 virus in the sample during
chromatography. Then the conjugates are bound by the COVID-19
monoclonal antibody fixed on the membrane, and a red line appears
in the test area (T). If it is negative, there's no red line in the
test area (T). Whether the sample contains COVID-19 antigen or not,
a red line will appear in the quality control area (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
