qualitative detection of SARS-CoV-2 virus-specific antibodies IgM
in human serum or plasma in vitro. SARS-CoV-2 is a new type of virus, belonging to the β novel
coronavirus which have envelope, round or elliptic particles, mostly pleomorphic with a diameter of 60-140nm.
Its genetic characteristics were significantly different from those of SARSr-CoV or MERSr-CoV.
Actually, its similarity with bat SARS-like coronavirus (bat-SL-CoVZC45) is more than 85%. SARS-CoV-2 can be
found in human respiratory epithelial cells in about 96 hours when cultured in vitro, while it
takes about 6 days in Vero E6 and huh-7 cell lines.
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
