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.
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.
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 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.
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.
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.
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.
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.
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.
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 |