Immuno-assay Kit for Antibody IgG to Tuberculosis (TB)
INTENDED USE
Rapid Gold Immuno-assay Kit for Antibody IgG to Tuberculosis
(TB)*** is an in vitro immunoassay for the qualitative
determination of Anti-TB antibody IgG in human serum or plasma in
one step. It is for diagnosis of early infection and epidemic
survey.
PRINCIPLE
The kit uses one step method to detect anti-TB antibodies IgG in
serum or plasma. The purified specific recombinant TB antigen is
immobilized on the nitrocellulose membrane at the test line region
and another specific TB Ag conjugated to the colloidal gold is
coupled on the label pad. To perform the test, a sample is added to
the sample well of the test card. The sample flows through to the
label pad. If the sample contains Antibody IgG to Tuberculosis, the
antibody will bind to the antigen coated on the colloidal gold
particles to form antibody-antigen-gold complexes. These complexes
move on the nitrocellulose membrane by capillary action toward the
test line region, and react with specific recombinant TB antigen to
produce a pink color on the membrane. A second red control line
will always appear in the result window to indicate that the test
has been correctly performed and the test device functions
properly. If Antibody IgG to Tuberculosis (TB) is not present or
lower than the detection limit of the test, only the control line
will be visible. If the control line dose not developed, the test
is invalid. The pink color intensity will reflect the antibody
intensity in the sample. The test is fast and easy to operate.
Product details
Description
Delivery
Within 48 hours
Packaging Specifications
25 tests/box
Country Of Origin
China
Manufacturer
24months
Preservation method
2℃-30℃
Specimen
urine
Assification
class1
Type
Reply Test
TEST PROCEDURE
1.Bring Membrane Plate and samples to room temperature (20-30°C)
before use (approximately 30 minutes).
2.Remove the test cassette/strip from the sealed foil pouch and
place the plate on flat desk.
3. Deliver 2 drops (80 -100 μL) of the sample to the sample
well/sample pad .
4. Read the result between 15-20 minutes. A strong positive sample
may show result earlier.
PRECAUTIONS
Both plate and sample should be with room temperature 20-25°C
Test sample must be fresh.
The result after 20 minutes is invalid.
Diluted sample may generate false positive result
Bacteria contamination, serious hemolysis, jaundice and high lipid
blood will cause wrong result. The sample should be re-collected.
Wrong result might be caused by expired kit or problematic samples.
SAMPLE COLLECTION AND PRESERVATION
Blood serum samples are routinely prepared form vein. Blood plasma
sample are routinely prepared with routine amount of anticoagulant
such as heparin or sodium citrate. Samples may be stored at 2-8°C
within five days without interfering with the assay performance.
For long-term storage of specimens, -20°C or colder is recommended.
Repeated freezing and thawing of specimens is not recommended and
may cause erroneous results. Samples with cloud or precipitation
should be centrifugated or filtered before test. Prevent serum from
bacteria contamination during collection and storage.
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
