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Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

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Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

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Brand Name : ZOSBIO

Model Number : 2019-NCoV Neutralizing Antibody

Certification : CE BfArm

Place of Origin : China

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 Validity Period

Composition : Detection card, sample buffer

term of validity : twelve months

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2019 Ag Rapid Test Kit Neutralizing Antibody Rapid Test Validity Period

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 kind of novel coronavirus, belonging to long.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.
Infection or vaccination in novel coronavirus in 2019 will trigger an immune response and produce antibodies in the blood. Secreted antibodies can prevent virus infection. After infection, they will stay in the human circulatory system for months to 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 was used in the kit. The detection card includes quality control line C, detection T, and reference line r.Detection capillary sample (serum/plasma and whole blood) upward diffusion loading, binding and S-RBD manufacturer plate combined with immobilized ACE2 in NC membrane protein detection and signal position line signal. 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 combining with ACE2, which leads to the decrease of signal value, which is negatively correlated with neutralizing antibody content. When neutralizing antibody concentration is high enough, 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 paper consists of absorbent paper, nitrocellulose membrane, sample pad, binding 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 the bonding pad contains the label 2019 nCoV Ab.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


The storage temperature is 2℃~ 30℃ and the validity period is 12 months.
The validity period of aluminum foil bag is 1 hour.
Production batch number: see the label for details.
Expiry date: see the label for details.

Sample Requirements


1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended matter in the sample will 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 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 storage time of serum and plasma samples at room temperature shall not exceed 8 hours.
It can be stored at 2-8℃ for 5 days and below -20℃ 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. All reagents should be returned to room temperature before testing, and testing 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) into 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


Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period
Explanation of test card:
1. invalid result: the quality control line (line c) is invalid and needs to be re-tested.
2. Negative result: the appearance color of the detection line (T line) is higher than or equal to that of the reference line (R line), the quality control line (C line) and the reference line (R line).
3. Positive results: The red band can't see that the test line (T line), or the red color band, the test line (T line) is lower than the reference line (R line) and the quality control (c) line and reference line (R line) are colored.

Limitation of Test Method


This kit is used for qualitative analysis, only for in vitro auxiliary diagnosis.
2. Make sure to add the right amount of samples for testing. Too much or too little sample size may lead to inaccurate results.
3. Hemolysis, blood lipid, jaundice, sample contamination, etc. 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 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. Reagents 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.

Logo interpretation


Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

Do not re-use

Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

Store at 2℃~30℃

Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

Consult instructions for use

Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

In vitro diagnostic medical

device

Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

Batch code

Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

Use-by date
Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity PeriodKeep dry

Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

Keep away from sunlight

Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

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Coronavirus 2019 Rapid Ag Test Kit Neutralizing Rapid Antibody Test Validity Period

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