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2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Limitation Of Test Method

Henan Lantian Medical Supplies Co.,Ltd.

2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Limitation Of Test Method

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Brand Name : ZOSBIO

Model Number : 2019-NCoV Neutralizing Antibody

Certification : CE BfArm

Place of Origin : Henan

MOQ : To be negotiated

Price : To be negotiated

Supply Ability : 10000 Kit/Kit per Day

Delivery Time : To be negotiated

Packaging Details : Kit

Product name : 2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Limitation Of Test Method

Composition : Detection card, sample buffer

term of validity : 12 months

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2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Limitation Of Test Method

Intended Use


The kit is used to qualitatively detect novel coronavirus neutralizing antibodies in human serum, plasma and whole blood samples.
Corona beer is a new coronavirus and a long novel coronavirus. Com coronavirus. Can cause viral pneumonia, the main clinical manifestations are fever, fatigue and dry cough. A few patients also have symptoms such as nasal congestion, runny nose, sore throat and diarrhea. Critical illness usually develops dyspnea and/or hypoxemia after one week, and rapidly develops into acute respiratory distress syndrome, septic shock, refractory metabolic acidosis and coagulation dysfunction.
Novel coronavirus infection or vaccination of 2019 will cause immune response and antibody production in blood. Secreting antibodies can prevent virus infection. After infection, they will stay in the human circulatory system for several months to several years, where they will quickly and firmly combine with pathogens to prevent virus replication. These antibodies are called neutralizing antibodies. Neutralizing antibody test can determine whether a person has the ability to prevent virus infection.

Principle of Detection


Immunochromatography is used in the kit. Comprises a check card quality control line c, a detection line t and a reference line R .. Samples (serum/plasma and whole blood) are detected by diffusion loading and binding, and S-RBD manufacturing plate is combined with immobilized ACE2 for NC membrane protein detection and signal localization line. If there is a neutralizing antibody in the sample, it will combine with the labeled S-RBD antigen when it flows through the labeled S-RBD antigen. Neutralizing antibody prevents S-RBD from binding to ACE2, which leads to the decrease of signal value negatively correlated with neutralizing antibody content. When the neutralizing antibody concentration is high enough, the T-ray is colorless. Whether the reference lines R and QC C are T-line coloring. Use quality control line c
If there is no color display on the C line, the test is invalid and the sample must be retested.

Main Components


The kit consists of a test card and a sample buffer.
Test card: It consists of aluminum foil bag, desiccant, test strip and plastic card. The test strip consists of absorbent paper, nitrocellulose membrane, sample pad, adhesive pad and rubber plate. T-line (detection line) of nitrification membrane covers ACE2 protein, C-line (QC line) covers Ab on QC line, R-line (reference line) covers reference Ab, and pad contains label 2019 nCoV Ab.
Sample buffer: phosphate, sodium azide, etc.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended solids in the sample will affect the experimental results and should be removed by centrifugation.
3. Anticoagulation: heparin anticoagulation, EDTA anticoagulation and sodium citrate anticoagulation have no obvious effect.
4. Blood collection should be conducted by professionals. Serum/serum/plasma test is recommended. In emergency or special cases, the whole blood samples of patients can also be used for rapid detection.
5. The preservation time of serum and plasma samples at room temperature shall not exceed 8 hours.
It can be stored at 2-8 C for 5 days and below-20 C for 6 months, but repeated freezing and thawing should be avoided. Whole blood samples should not be frozen, and should be stored at 2 C to 8 C for no more than 48 hours.

Test Method


Read the operating instructions carefully before testing. Before the test, all reagents should be returned to room temperature, and the test should be conducted at room temperature.
1. Take out the test card from the box and use it within 1 hour.
2. Add 20 L of sample (serum, plasma or whole blood) to the filling hole of the test card, add 2 drops (~60 L) of sample buffer, and then start timing.
3. React at room temperature for 10-15 minutes, and then read the results. Invalid after 20 minutes.

Interpretation of Test Results


2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Limitation Of Test Method

Test card description:
1. invalid result: the quality control line (line c) is invalid and needs to be tested again.
2. Negative result: the appearance color of the detection line (T line) is higher than or equal to the reference line (R line), quality control line (C line) and reference line (R line).
3. Positive results: the test line (T-line) or red band can't be seen in the red band, the test line (T-line) is lower than the reference line (R-line), and the quality control line (C) and reference line (R-line) are colored.

Limitation of Test Method


The kit is used for qualitative analysis and only for in vitro diagnosis.
2. Make sure to add the right amount of samples for testing. Too many or too few samples may lead to inaccurate results.
3. Hemolysis, blood lipid, jaundice, sample pollution, etc., which may affect the test results, should be avoided as far as possible.
4. The test results of this reagent are for clinical reference only, and should not be used as the only basis for clinical diagnosis and treatment. Combine all clinical and laboratory results to make a final diagnosis of the disease.

Precautions


1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be recycled.
3. Read the instructions carefully before operation, and conduct the experimental operation in strict accordance with the reagent instructions.
4. Avoid conducting experiments under harsh environmental conditions (including 84 disinfectant, sodium hypochlorite, acid, alkali, acetaldehyde and other high-concentration corrosive gases, dust, etc.). Laboratory disinfection should be carried out after the experiment.
5. All samples and reagents used should be regarded as potentially infectious substances and treated according to local regulations.
6. Reagent should be used within the validity period indicated on the outer package. The test card should be taken out of the aluminum foil bag as soon as possible after being taken out to prevent moisture.

Company profile


2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Limitation Of Test Method2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Limitation Of Test Method2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Limitation Of Test Method2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Limitation Of Test Method


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