This kit is used for qualitative detection of 2019-NCOV neutralizing antibodies in human serum, plasma and whole blood samples.
Corona beer 2019 Is Elong. A novel corona virus belonging to corona virus. May cause viral pneumonia, the main clinical symptoms are fever, tiredness, dry cough. A small number of patients also show symptoms such as stuffy nose, runny nose, sore throat and diarrhea. Dyspnea and/or hypoxemia usually develop after one week in severe cases. Examples of severe cases are acute dyspnea syndrome, septic shock, refractory metabolic adoxis, and coagulation disorder.
19 NCOV infection or vaccination causes an immune response that produces antibodies in the blood. Secreted antibodies protect against viral infection. After infection, they stay in the body's circulatory system for months to years, rapidly binding to the pathogen to prevent the virus from replicating. These antibodies are called neutralizing antibodies. Neutralization antibody test can determine whether a person has the ability to prevent viral infection.

Principle of Detection

The accessory components were implemented using IMO chromaticity. The test card contains quality control line C, test line T and reference line R. Updiffusion load, binding, and capillary action of S in test samples (serum/plasma and whole blood) The S-RBD manufacturer's pad combines ACE2, which is fixed to the NC membrane protein, to detect position line signals and send signals. In the presence of neutralizing antibodies in the sample, the neutralizing antibodies bind to labeled S-RBD antigens as they flow through the labeling plate. Neutralizing antibodies prevent S-. When S-RBD binds to ACE2, the signal value decreases, and the neutralizing antibody content is negatively correlated. When the concentration of neutralizing antibody is high enough, the T-line becomes colorless. Reference line R and quality control line C will be colored regardless of whether T is colored or not. Whether to use quality control line C
If there is no color display on quality control line C, the test is invalid and the sample needs to be tested again.

Main Components

The kit consists of test cards and sample buffers.
Test card: aluminum foil bag, desiccant, test strip, plastic card composition. The test paper consists of absorbent paper, nitrocellulose film, sample pad, binding pad and rubber plate. Nitrifying membrane T line (test line) covers ACE2 protein, C line (QC line) covers QC line Ab, R line (reference line) covers reference Ab, and binding pad contains label 2019nCoVAb.
Sample buffer: phosphoric acid, sodium nitrite, etc.

Storage Conditions and Validity

Storage temperature is 2℃ ~ 30℃, effective for 12 months.
Aluminum foil bags are valid for 1 hour.
Production Lot Number: Refer to the label for details.
Expiry date: Refer to the label for details.

Sample Requirements

1. Collection of serum, plasma or whole blood samples.
2. Sediment or plankton in the sample may affect the experimental results, so it needs to be removed by centrifugation.
3. Anti-coagulant: luffa anti-coagulant, EDA anti-coagulant, sodium citrate anti-coagulant effect is not obvious.
4. Blood collection by a medical expert is required. Serum/serum/plasma tests are recommended. Whole blood samples from patients can also be used for rapid testing in emergency or special situations.
5. Serum and plasma samples should not be kept at room temperature for more than 8 hours.
Can be stored for 5 days from 2 °C to 8°C, less than -20°C can be stored for 6 months, but please avoid repeated freezing melting. Blood samples are ice-free and must be kept at 2°C ~ 8°. C within 48 hours.

Test Method

Please read the instructions carefully before the test. All reagents should be returned to room temperature prior to test, which must be carried out at room temperature.
1. Remove the test card from the package and use it within 1 hour.
2. Add 20L sample (serum, plasma or whole blood) to the filling hole of the test card, add 2 drops (~ 60L) of sample buffer memory and start timing.
3. Reaction at room temperature for 10 to 15 minutes, read the results. Invalid after 20 minutes.

Interpretation of Test Results

Test card explanation:
1. Invalid result: The response line of quality management line (Line C) is not invalid and needs to be tested again.
2. Negative result: the test line (T line), color appearance is greater than the reference line (R line), quality management line (C line) and reference line (R line) color.
3. Positive results: There is no red band on the test line (T line), the red band on the test line (T line) is lower than the reference line (R line), and the quality management line (C line) and the reference line (R line) are colors.

Limitation of Test Method

This kit is for qualitative testing and Invitro assisted diagnosis only.
2. Confirm that the appropriate number of test samples has been added. If the sample size is too large or too small, the result may be incorrect.
3. Hemolysis, lipids, jaundice, and contaminated samples may affect the results and must be avoided.
4. The test results of the reagent are for clinical reference only, and cannot be used as the sole basis for clinical diagnosis and treatment. A final diagnosis of the disease must be made after a comprehensive evaluation of all clinical and examination results.

Precautions

1. This product is only used for Invitro diagnosis.
This product is disposable and can't be reused.
3. Please read the instructions carefully before operation, and strictly follow the instructions of reagent for experimental operation.
4. Do not perform the experiment under harsh environmental conditions (84 disinfectant, sodium hypochlorite, acid, alkali, acetaldehyde, other highly corrosive gases, dust, etc.). Please disinfect in laboratory after experiment.
5. All samples and reagents used are treated as potentially infectious substances and are disposed of in accordance with regional regulations.
6. The reagent must be used within the expiry date stated on the package. To prevent moisture, the test card must be used as soon as possible after it is removed from the foil bag.

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 Efficient

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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