SARS-CoV-2 Coronavirus Neutralizing Antibody Rapid Test

Store at 2℃ ~ 30℃ for 12 months.
The validity period of the aluminum foil bag is 1h after unpacking.
Batch No. : See label for details.
Expiration date: see label for details.

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. The sediment and suspended matter in the sample may affect the experimental results, and should be removed by centrifugation.
3. Anticoagulants: the use of heparin, EDTA and sodium citrate anticoagulants had no significant effect.
4. Blood collection should be performed by medical professionals. Serum/plasma testing is recommended as a priority. In emergency or special circumstances, a patient's whole blood sample can also be used for rapid testing.
5. Serum and plasma samples should not be stored at room temperature for more than 8h. They can be stored at 2℃ to 8℃ for 5 days and below -20℃ for 6 months, but repeated freeze-thaw cycles should be avoided. The whole blood sample shall not be frozen and stored at 2℃ ~ 8℃ for no more than 48h.

Test Method

Read the instructions carefully before the test. Restore all reagents to room temperature before testing. The test should be conducted at room temperature.
1. Take the test card out of the packaged reagent bag and use it within 1 hour.
2. Add 20μl sample (serum, plasma or whole blood) to the filling well of the test card, then add 2 drops (about 60μl) sample buffer, and start timing.
3. Reaction at room temperature for 10 ~ 15 minutes to read the results. The result was invalid after 20 minutes.

Interpretation of Test Results

Judgment diagram of test card results:
1. Invalid results: no reaction line appeared on the quality control line (line C), and the test was invalid, so the experiment should be redone.
2. Negative results: red bands appear on the test line (Line T), and the color rendering is higher than or equal to the control line (Line R), quality control line (Line C) and control line (Line R).
3. Positive result: no red band appeared on the test line (Line T) or red band appeared on the test line (Line T), but the color rendering was lower than that of the control line (Line R), and the quality control line (Line C) and the control line (Line R).

Limitation of Test Method

1. This kit is for qualitative detection and is only used for in vitro auxiliary diagnosis.
2. Make sure you add the right amount of samples for testing. Too many or too few samples may result in inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may affect test results and should be avoided.
4. The test results of this reagent are only for clinical reference and should not be used as the sole basis for clinical diagnosis and treatment. The final diagnosis of the disease should be made after a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

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1. Analysis of specificity
1.1 Cross-reaction: The following types of antibodies were evaluated for interference with reagents, and the results showed no cross-reaction.

1.2 Interfering Substances: The potential interference of the following substances in the Novel Coronavirus (2019-nCoV) neutralizing antibody test program was evaluated by adding the following substances to a specified concentration sample. The results showed that all kinds of interfering substances did not interfere with the detection results of this reagent.

2. Clinical study: 120 positive samples and 300 negative samples were selected by using the marketed Novel Coronavirus (2019-nCoV) IgG detection reagent (colloidal gold method) as the contrast reagent, and the results were summarized as follows:

Precautions

1. This product is only used for in vitro diagnosis.
2. This product is a disposable product, which can not be recycled and reused after use.
3. Read the operation instructions carefully before operation, and carry out the experiment in strict accordance with the reagent instructions.
4. Avoid conducting the experiment in harsh environment (such as environment containing high concentration of corrosive gas and dust such as 84 disinfectant, sodium hypochlorite, acid and alkali or acetaldehyde). Laboratory disinfection should be carried out after the end of the experiment.
5. All samples and used reagents should be regarded as potentially infectious substances and disposed of in accordance with local regulations.
6. Reagents should be used within the validity period marked on the outer package. The detection card should be used as soon as possible after it is taken out of the aluminum foil bag to prevent moisture.

Logo interpretation

 

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	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

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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

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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.