Coronavirus Disease 2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Kit
Brand Name:ZOSBIO
Certification:CE BfArm
Model Number:2019-NCoV Neutralizing Antibody
Minimum Order Quantity:To be negotiated
Delivery Time:To be negotiated
Place of Origin:Henan,China
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Location:
Zhengzhou Henan China
Address:
Office Address: Building 4, No. 51 Jingbei 3rd Road, Jingkai Zone, Zhengzhou City. Henan Province,China.
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Product Details
Coronavirus Disease 2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Test Card
Intended Use
The kit was used to qualitatively detect the 2019-nCoV neutralizing
antibodies in human serum, plasma, and whole blood samples.
2019 Corona Beer Corona Beer is a novel coronavirus that belongs to
the elong.com coronavirus.It can cause viral pneumonia, and the
main clinical manifestations are fever, fatigue and dry cough.A
small number of patients will also appear nasal congestion, runny
nose, sore throat, diarrhea and other symptoms.Critical cases
usually develop dyspnea and / or hypoxemia just a week later, and
critical cases rapidly progress to acute respiratory distress
syndrome, septic shock, refractory metabolic acidosis, and
coagulation disorders.
A 2019 nCoV infection or vaccination triggers an immune response
that produces antibodies in the blood.Secreted antibodies can
prevent viral infection.After infection, they stay in the body's
circulatory system for months to years, where they quickly and
firmly bind to the pathogen to prevent virus replication.These
antibodies are called neutralizing antibodies.Neutralizing antibody
tests can determine whether a person has the ability to prevent
viral infection.
Principle of Detection
Kits were carried out by immunochromatography.The detection card
includes the quality control line C, the detection line T, and the
reference line r.Detection capillary action of samples (serum /
plasma and whole blood) for upward diffusion loading, binding and
S-RBD manufacturer plates bind immobilized ACE2 in NC membrane
protein to detect and signal position line signals.If a
neutralizing antibody is present in the sample, it binds to the
labeled S-RBD antigen when flowing through the labeled
disc.Neutralizing antibodies prevent S-RBD from binding to ACE2,
resulting in reduced signal values, a negative correlation with
neutralizing antibody content, and the t-ray is colorless when
neutralizing antibody concentrations are sufficiently
high.Reference lines R and QC C are colored for T lines or not.Use
quality control line C
Quality control If the C line is not displayed in color, the test
is invalid and the sample must be re-tested.
Main Components
The kit consisted of a test card and a sample buffer.
Test card: composed of aluminum foil bag, desiccant, test strip and
plastic card.Among them, the test paper consists of water
absorption paper, nitrocellulose film, sample pad, binding pad, and
rubber plate.Nitrification membrane T line (detection line) covers
ACE2 protein, C line (QC line) covers Ab on QC line, R line
(reference line) covers reference Ab, and the binding pad contains
tag 2019 nCoV Ab.
Sample buffer: phosphate, sodium azide, etc.
Storage Conditions and Validity
Storage temperature is 2℃ to 30℃, valid for 12 months.
The aluminum foil bag is valid for one hour.
Production batch number: see the label for more information.
Validity period: see the label for details.
Sample Requirements
1. Collection of serum, plasma, or whole blood samples.
2. Precipitates and suspended objects in the sample may affect the
experimental results and should be removed by centrifugation.
3. Anticoagulant: Heparin anticoagulant, EDTA anticoagulant and
sodium citrate anticoagulant are not obvious.
4. Blood collection should be carried out by professionals.Serum /
serum / plasma testing is recommended.Whole blood samples of
patients can also be used for rapid detection in emergency or
special cases.
5. Serum and plasma samples shall not be stored for time at room
temperature than 8 hours.
The 2-8°C can be kept for 5 days and below the-20°C for 6 months,
but repeated freeze and thawing should be avoided.Whole blood
specimens should not be frozen and should be kept at 2°C to 8° C
for no more than 48 hours.
Test Method
Read the operating instructions carefully before testing.All
reagents should be put back to room temperature before testing, and
the testing should be performed at room temperature.
1. Remove the test card from the package kit and use it within one
hour.
2. Add 20 L samples (serum, plasma, or whole blood) to the test
card filling hole, add 2 drops (~60 L) of the sample buffer, and
then start the timing.
3. Reaction at room temperature for 10-15 minutes and read the
results.Invalid after 20 minutes.
Interpretation of Test Results
Test card interpretation:
1. Invalid results: the quality control line (line C line) is
invalid, and they need to be re-tested.
2. Negative result: the test line (T line), the color appearance is
higher than or equal to the color of the reference line (R line),
the quality control line (C line) and the reference line (R line).
3. Positive result: the red band can not be seen on the test line
(line T line), or the color of the red band on the test line (line
T line) is lower than the reference line (line R line), and the
quality control line (line C) and the reference line (line R line)
are colored.
Limitation of Test Method
1 This kit was used for a qualitative assay and only for in
vitro-assisted diagnosis.
2. Ensure that an appropriate amount of samples is added for
testing.Too much or too little sample size may lead to inaccurate
results.
3. Hemolysis, blood lipid, jaundice, sample pollution and so on may
affect the test results, and should be avoided as far as possible.
4. The test results of this reagent are for clinical reference
only, and shall not be used as the only basis for clinical
diagnosis and treatment.After integrating all the clinical and
laboratory results, the final diagnosis of the disease was made.
Precautions
1. This product is only used for in vitro diagnosis.
2. This product is a disposable product and is not recyclable.
3. Read the instructions carefully before the operation, and
conduct the experimental operation in strict accordance with the
reagent instructions.
4. Avoid conducting experiments in harsh environmental conditions
(including 84 disinfectant, sodium hypochlorite, acid, alkali,
acetaldehyde and other high-concentration of corrosive gases, dust,
etc.).Laboratory disinfection shall be carried out after the
experiment.
5. All samples and reagents used shall be considered as potentially
infectious substances and treated in accordance with local
regulations.
6. Reagent shall be used within the validity period indicated on
the outer package.The test card shall be used as soon as possible
after removal from the foil bag to prevent damp.
Logo interpretation
| Do not re-use | Store at 2℃～30℃ | ||
| Consult instructions for use | In vitro diagnostic medical device | ||
| Batch code | Use-by date | ||
| Keep dry | Keep away from sunlight | ||
Authorized representative in the European Community | Manufacturer |
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Coronavirus Disease 2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Kit
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