Enzyme-linked immunosorbent assay for the detection HBeAg in serum
or plasma
2. SUMMARY AND PRINCIPLE OF THE TEST
1. The Hepatitis B e antigen is found to be related to Hepatitis B
viral infection. HBeAg is usually found in the early phase of
Hepatitis B viral 2. infection.
2. The titer of HBeAg rises rapidly during the period of virus
replication. The presence of HBeAg correlates with increasing
numbers of infectious viruses (Dane particles) and the presence of
viral specific DNA polymerase in serum.
3. During the HBeAg positive stage, hepatitis B patients are at
increasing risk of transmitting the virus to their contacts.
4. Persistent presence of HBeAg in the hepatitis B virus carrier is
often associated with chronic active hepatitis.
3. REAGENTS
Materials provided with the kits: 1.Microtiter Well coated with monoclonal anti-HBe: 96 tests in one
bag. 2.Negative Control: 0.5ml HBeAg Negative Control. 3.Positive Control: 0.5ml HBeAg Positive Control. 4.Enzyme Conjugate:.6 ml containing HRP-conjugated-anti-HBe 5.Wash Buffer Concentrate (20 x): 20 ml for 96 tests. The buffer
should be diluted 20 times with distilled water before use. 6.Substrate Solution A: 6 ml HRP Substrate for 96 tests. 7.Substrate Solution B: 6 ml TMB Chromagen Substrate for 96 tests. 8.Stop Solution: One bottle of 6 ml 2N Sulfuric Acid.
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
