Self Test Diagnostic Kit For IgM Antibody To 2019-NCoV Rapid Test
INTENDED USE
The Anti-TP ELISA is a qualitative enzyme immunoassay for the in
vitro detection of Treponema Pallidum (TP) infection, based on the
detection of total antibody to Treponema Pallidum in human serum or
plasma. It is intended for screening of blood donors and diagnosing
patients related to infection with TP.
Product details
Description
Test Time
5-20 miuntes
Packaging Specifications
Exp
two years
Manufacturer
BIOVANTION
Preservation method
Normal temperature
Assification
Class1
Package
carton/box
Sample Type
Pharyngeal
Interpretation of test results
To develop color on C line only
To develop color on both C line and T line;
To develop color on T line only
If no C line is developed, the assay is invalid regardless of any
color in the T line.
Samples should be processed according to infectious contaminants
and samples should be collected again.
Sample requirements
Serum and plasma samples were collected from the venous blood by
conventional method. The treatment of plasma sample: heparin
solution, sodium citrate solution and EDTA solution can be used to
anticoagulate blood.
Serum or plasma samples can be stored at 2 ~ 8 ℃ if tests will be
done within 5 days, otherwise stored at -20 ℃. No more than 3 times
of freeze-thaw.
The result of haemolysis sample test is invalid.
Samples containing suspended fibrin or polymer are recommended for
centrifugation and supernatant for testing. Hemolytic samples can
not be detected.
There should be no other microbial contamination in the samples to
be tested.
The specimen transfer box should have special identification. After
removing the specimen from the sealed bag, it must be sterilized by
ultraviolet or 75% ethanol spray.
Before use, the sample should be kept at room temperature for more
than 30 minutes, and the sample should be mixed before freezing.
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
freezing.
