This kit is used for the qualitative detection of 2019-nCoV neutralizing antibodies in human serum, plasma and whole blood samples.
2019 Corona Beer Corona Beer is a new type of coronavirus, which 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 also have symptoms such as nasal congestion, runny nose, sore throat and diarrhea. Dyspnea and/or hypoxemia usually develops in critical cases after one week, and critical cases rapidly progress to acute respiratory distress syndrome, septic shock, refractory metabolic acidosis, and coagulopathy.

2019 nCoV infection or vaccination triggers an immune response that produces antibodies in the blood. The secreted antibodies protect against viral infection. After infection, they remain in the body's circulatory system for months to years, where they quickly and firmly bind to pathogens to prevent viral 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

The kit was performed using immunochromatography.The test card contains the quality control line C, the test line T, and the reference line r.The capillary action of the test samples (serum / plasma and whole blood) upward diffusion load, binding and S-RBD manufacturer pad bound immobilized ACE2 in NC membrane proteins to detect and signal position line signals.If neutralizing antibodies are present in the sample, it binds to the labeled S-RBD antigen when it flows through the labeled pad.Neutralizing antibodies prevent S-RBD binding to ACE2, resulting in reduced signal value, negative correlation with neutralizing antibody content, and t-ray colorless when the neutralizing antibody concentration is sufficiently high.Reference lines R and quality control line C are colored regardless of whether the T line is colored or not.Use the quality control line C
Quality control If there is no color display on line C, 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: composed of aluminum foil bag, desiccant, test strip and plastic card.Among them, the test paper consists of water absorption paper, nitrosing cotton film, sample pad, binding pad and rubber plate.Nitrification membrane T line (detection line) covers ACE2 protein, and C line (QC line) covers Ab on the QC line, R line (reference line) covers reference Ab, and the binding pad contains the tag 2019 nCoV Ab.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity

The storage temperature is 2℃ to 30℃ and is valid for 12 months.
The aluminum foil bag is valid for one hour.
Production lot 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. Sediments and suspended solids in the sample may affect the experimental results and should be removed by centrifugation.
3. Anticoagulant: Heparin anticoagulant, EDTA anticoagulant, sodium citrate anticoagulant effect is not obvious.
4. Blood collection should be conducted by medical professionals.Serum / serum / plasma testing is recommended.Whole blood samples of patients can also be used for rapid detection in emergency or special circumstances.
5. Serum and plasma samples shall not be stored for more than 8 hours at room temperature.they
The 2-8°C can be stored for 5 days and below the-20°C for 6 months, but repeated freeze-thaw 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

Please 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 of the samples (serum, plasma, or whole blood) to the test card filling hole, add 2 drops of (~60 L) of the sample buffer, and then start the timing.
3. Reaction for 10 – 15 min at room temperature and read the results.Invalid after 20 minutes.

Interpretation of Test Results

Test card interpretation:
1. Invalid result: no reaction line on the quality control line (line C) is invalid, and it should be re-tested.
2. Negative result: test line (T line), color appearance 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 result: the red band is not visible on the test line (T line), or the red band on the test line (T line) color is lower than the reference line (R line), and the quality control line (line C) and the reference line (R line) are in color.

Limitation of Test Method

1 This kit was used for qualitative testing 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, lipids, jaundice, and contaminated samples may affect the test results, and should be avoided.
4. The test results of this reagent are for clinical reference only, and shall not be used as the sole basis for clinical diagnosis and treatment.After a comprehensive evaluation of all clinical and laboratory results, a final diagnosis of the disease should be made.

Precautions

1. This product is used 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 should 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

Basic Information

ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD

Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA

Tel:+86-371-55016575

Email:zosbio@zosbio.com

Web:www.zosbio.com

SUNGO Europe B.V.

Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

Company profile

2019 Coronavirus Disease Neutralizing Antibody Rapid Test Kit Card

Zhongxiu Science And Technology Co.,Ltd., is a high-tech enterprise engaged in the research and development, production and operation of in vitro diagnostic products. The in vitro diagnostic products developed by the company cover POCT series, microbial series, biochemical series and immune series reagents and supporting instruments.
The company has always adhered to the core concept of "fast and accurate, living up to life", committed to providing society with excellent products and services, and contributing to the cause of human health.

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