Sample Requirements

1.Collect serum, plasma or whole blood samples.

2.The sediment and suspended matter in the sample may affect the experimental results, andshould be removed by centrifugation.

3. Anticoagulant: Heparin, EDTA and sodium citrate anticoagulant have no significant effect.

4. Blood collection should be performed by professional medical personnel. It is recommended to give priority to serum/plasma test. In emergency or special circumstances, the patient's whole blood sample can also be used for rapid test.

5. Serum and plasma samples should not be stored at room temperature for more than 8h. They can be stored for 5 days at 2℃ to 8℃ and for 6 months below -20℃, but repeated freeze-thaw cycles should be avoided. Whole blood samples should not be frozen and it should be stored at 2℃～8℃ for no more than 48h

Test Method

Read the instructions carefully before testing. Please return all reagents to room temperature before testing, and the test should be performed at room temperature.

1.Take out the test card from the packaged reagent bag and use it within an hour.

2.Add 20μL of sample (serum, plasma or whole blood) to the loading well of the test card, then add 2 drops (about 60μL) of sample buffer and then start timing.

3. Read the result when reacting at room temperature for 10-15 minutes. The result is invalid after 20 minutes

Interpretation of Test Results

Interpretation of test card:

1. Invalid result: It is invalid with no reaction line on the quality control line (C line), and the test should be carried out again.
2. Negative result: A red band appears on the test line (T line), and the color rendering is higher than or equal to the reference line (R line), and the quality control line (C line) and reference line (R line) are colored.
3. Positive result: No red band appears on the test line (T line), or the red band on the test line (T line) is less coloring than the reference line (R line), and the quality control line (C line) and the reference line (R Line) are colored.

Limitation of Test Method

1. This kit is for qualitative detection and is only used for in vitro auxiliary diagnosis.
2. Make sure to add an appropriate amount of sample for test. Too much or too little sample volume may result in 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

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

1.2Interfering substances: The following concentrations of substances were added to the samples at the specified concentrations to evaluate their potential interference in 2019-nCoV neutralization Ab test project. The results showed that all kinds of interfering substances did not interfere with the test results of this reagent.

2.Clinical study: Using the marketed 2019-nCoV IgG Ab 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 disposable, which cannot be recycled and reused.
3. Read the instructions carefully before operation, and carry out the experimental operation in strict accordance with the reagent instructions.
4. Avoid conducting experiments in bad environmental conditions (the environments containing 84 disinfectant, sodium hypochlorite, high-concentration corrosive gases such as acid and alkali or acetaldehyde, and dust). Laboratory disinfection should be carried out after 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 test card should be used as soon as possible after being 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.