Hospital, Medical Center,Self High AccuracyAnti-TP ELISA Test Kit
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 Detail
Description
Packaging Specifications
50 tests/box
Country Of Origin
China,BeiJing
Detection Limit
24 months
Storage
4-30℃
Specimen
serum, plasma, whole blood,fingertip blood
Instrument classification
Class I
Product Type
Repid Test
Accuracy
99.9%
Application
Hospital, Medical Center,self
ASSAY PROCEDURE
Prepare Reagents: Dilute 1 volume of Concentrated Washing Buffer
(20×)with 19 volumes of distilled water, mix well.
Add Samples: Open the foil pouch and remove the Microplate. Set up
1 well as Blank, 2 wells as negative control, 2 wells as positive
control. After dispensing 50μL of Sample Diluent , dispense 50μL of
sample or negative control or positive control to the respective
wells. Gently vibrating the plate.
Incubate: Cover the Microplate with plate cover and incubate the
Coated Microplate in a thermostat-controlled water-bath or
microplate incubator at 37℃ for 60 minutes.
Wash the Plate: Remove the plate cover. Aspirate the contents of
all wells. Fill the wells with the diluted washing buffer ( 10~20
seconds to soak) then aspirate again. Repeat the procedure for 5
times. Make sure that the rest volume is minimal, by tapping plate
onto absorbent paper.
Add Conjugate: Add 100μL of conjugate to each well (except for the
blank well).
Incubate: Cover the Microplate and incubate the plate at 37℃ for 30
minutes.
Wash the Plate: Repeat the wash procedure as in step 4.
Add Substrate: Add 50μL of Substrate Solution A and 50μL of
Substrate Solution B to each well, mix well. Cover and incubate at
37℃ for 30 minutes.
Stop reaction: Add 50μL Stop Solution to each well, mix well.
Read the absorbance at 450 nm. If a dual wavelength measurement is
used, the reference wavelength should be selected from 620nm to
690nm.
PRECAUTIONS
Allow all kit components to reach room temperature before use.
Follow the direction insert to control the reaction temperature and
time strictly.
Do not mix components of different lot numbers to use.
The kit should be store at 2-8℃. Do not use kit components beyond
their expiration date.
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
