ZOSBIO 2019-Ncov Neutralization Antibody Test Kit

It can be stored at 2 ℃ to 30 ℃ for 12 months.
After the aluminum foil bag is unsealed, it is valid for 1 hour.
Product batch number: 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 results of the experiment and should be removed by centrifugation.
3. Anticoagulant: The use of heparin, EDTA and sodium citrate anticoagulant has no significant effect.
4. Blood collection should be performed by professional medical personnel. It is recommended to give priority to serum/plasma testing. In emergency or special circumstances, the 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 8 hours. They can be stored at 2°C to 8°C for 5 days, and at -20°C they can be stored for 6 months but avoid repeated freezing and thawing. Whole blood samples should not be frozen and stored at 2℃～8℃ for no more than 48h.

Test Method

Read the instruction manual carefully before testing. Please return all reagents to room temperature before the test, and the test should be performed at room temperature.
1. Take out the test card from the packaged reagent bag and use it within 1 hour.
2. Add 20μL of sample (serum, plasma or whole blood) to the sample hole of the test card, and then add 2 drops (about 60μL) of sample buffer to start timing.
3. Read the result when reacting at room temperature for 10-15 minutes. The read result is invalid after 20 minutes.

Interpretation of Test Results

Test card result judgment icon:
1. Invalid result: the quality control line (line C) has no response line, and the test is invalid. The experiment should be repeated.
2. Negative result: A red band appears on the test line (T line), and the color is higher than or equal to the control line (R line), and the quality control line (C line) and control line (R line) are colored.
3. Positive result: there is no red band on the test line (T line) or red band on the test line (T line), but the color is lower than the control line (R line), the quality control line (C line) and the control line (R Line) color development.

Limitation of Test Method

1. This kit is a qualitative test and is only used for in vitro auxiliary diagnosis.
2. Make sure to add an appropriate amount of sample for testing. Too much or too little sample size may cause inaccurate results.
3. Hemolysis, lipemia, jaundice and contaminated samples may affect the test results, and these samples should be avoided.
4. The test results of this reagent are for clinical reference only, 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 following substances were added to the specified concentration samples to evaluate their potential interference in the new coronavirus (2019-nCoV) neutralization antibody test project. The results show that various interfering substances will not interfere with the test results of this reagent.

2. Clinical research: Using the marketed new coronavirus (2019-nCoV) IgG antibody detection reagent (colloidal gold method) as a comparison reagent, 120 positive samples and 300 negative samples were selected for testing. The results are summarized as follows:

Precautions

1. This product is only used for in vitro diagnosis.
2. This product is a one-time use product, after use, it cannot be recycled and reused.
3. Read the instruction manual carefully before operation, and carry out the experimental operation in strict accordance with the reagent manual.
4. Avoid conducting experiments in harsh environments (such as environments containing 84 disinfectant, sodium hypochlorite, acid-base or acetaldehyde and other high-concentration corrosive gases and dust) conditions. Laboratory disinfection should be performed after the experiment.
5. All samples and reagents after use should be regarded as potentially infectious substances, and should be disposed of in accordance with local regulations when they are discarded.
6. Please use the reagents within the validity period indicated on the outer packaging, and use the test card as soon as possible after taking it 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.