The kit is used for qualitative detection of 2019 nCoV neutralizing antibodies in human serum, plasma, and whole blood samples.
Corona beer is Novel Coronavirus, belonging to Elong. Com coronavirus. Can cause viral pneumonia, the main clinical manifestations are fever, fatigue and dry cough. A small number of patients also experience nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Critical cases usually develop dyspnea and/or hypoxemia one week later, and critical cases rapidly progress to acute respiratory distress syndrome, septic shock, refractory metabolic acidosis, and cotting disorders.
2019 nCoV infection or vaccination triggers an immune response that produces antibodies in the blood. Secreting antibodies protects against viral infection. After infection, they stay in the body's circulatory system for months to years, where they bind quickly and firmly to pathogens to prevent virus replication. These antibodies are called neutralizing antibodies. Neutralizing antibody tests determine whether a person is able to protect against viral infection.

Principle of Detection

The kit was performed by immunochromatography. The test card includes quality control line C, test line T and reference line R. Capillary action of samples (serum/plasma and whole blood) for upward diffusion loading, binding, and immobilization of ACE2 in S-RBD manufacturer plate binding NC membrane protein to detect and signal localization line signals. If neutralizing antibodies are present in the sample, they bind to the labeled S-RBD antigen as they flow through the labeled disk. Neutralizing antibody prevents S-RBD from binding to ACE2, resulting in a decrease in the signal value, which is negatively correlated with the content of neutralizing antibody. When the concentration of neutralizing antibody is high enough, T-ray is colorless. Whether reference lines R and QC C are colored for T lines. Use quality control line C
Quality control If there is no color display for line C, the test is invalid and the sample must be retested.

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

The storage temperature is 2 ~ 30 ℃, and the validity period is 12 months.
The validity period of aluminum bag is one hour.
Production number: please refer to the label for details.
Validity period: please refer to 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 result: Quality control line (C line) is invalid and needs to be re-tested.
2. Negative result: the color appearance of test line (T line) is higher than or equal to the color of reference line (R line), quality control line (C line) and reference line (R line).
3. Positive results: No red band can be seen on the test line (T line), or the color of the red band on the test line (T line) is lower than the reference line (R line), and the quality control line (C line) and reference line (R line) are colored.

Limitation of Test Method

This kit is used for qualitative analysis and in vitro auxiliary diagnosis only.
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 lipids, jaundice and sample contamination may affect test results and should be avoided as far as possible.
4. The test results of this reagent are only for clinical reference and shall not be used as the sole basis for clinical diagnosis and treatment. The final diagnosis of the disease was made after combining all clinical and laboratory results.

Precautions

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

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