Enzyme-linked immunosorbent assay for the detection of antibody to
Hepatitis B Virus surface antigen in serum or plasma.
1. SUMMARY
Hepatitis B is an infectious illness caused by hepatitis B virus
(HBV) which infects the liver of hominoidea, including humans, and
causes an inflammation called hepatitis. HBV is excreted in body
fluids such as semen, saliva, blood and urine in persons with acute
or chronic infection. The hepatitis B virus is known as a
blood-borne virus because it is transmitted from one person to
another via blood or fluids contaminated with blood. Classification
of a hepatitis B infection requires the identification of several
serological markers expressed during three phases (incubation,
acute and convalescent) of the infection.
ASSAY PROCEDURE:
It is strongly advised to analyze each specimen and controls in
duplicate. All the reagents should equilibrate to room temperature
before use.
For each test, set one blank well as background control, two
positive and two negative controls.
Add 50μl positive control, Negative control, and Specimen into
their respective wells. Neither samples nor HRP-Conjugate should be added into the Blank
well.
Add 50 μl Enzyme Conjugant to each well except the Blank. Mix it
gently by swirling the microtiter plate on flat bench for 1 minute.
Do not add Enzyme Conjugate to the blank well.
Cover wells with seal paper, Place the microtiter plates into a
humidified box, and incubate at 37°C for 30 minutes.
Wash each well 5 times by filling each well with diluted wash
buffer, then inverting the plate vigorously to get all water out
and blocking the rim of wells on absorbent paper for a few seconds.
Add one drop (50 ul) of Substrate Solution A (HRP-substrate) to
each well, then add one drop (50 ul) of Substrate Solution B (TMB)
to each well. Mix gently and incubate at 37°C for 15 minutes. .
Add 1 drop (50 ul) of Stop Solution to each well to stop the color
reaction. Read the OD value at 450 nm/630 nm with dual filter plate
reader. It is option to read the OD value at 450 nm with single
filter plate reader. (using the OD value of the blank well to correct all the OD reading
from all wells)
3. REAGENTS
Materials provided with the kits:
Item
Description
96T
480T
1
Microtiter Well
1
5
2
Negative Control
0.5ml
2.5ml
3
Positive Control
0.5ml
2.5ml
4
Enzyme Conjugate
6ml
30ml
5
Wash Buffer Concentrate (20x)
20ml
100ml
6
Substrate Solution A
6ml
30ml
7
Substrate Solution B
6ml
30ml
8
Stop Solution
6ml
30ml
9
User manual
1 copy
5 copy
Company Profile
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