2019 NCoV Coronavirus Neutralizing Antibody Rapid Test Immunochromatography

It is stored for months at temperature.
The shelf life of the aluminum foil bag is one hour after opening the box.
See the product label for more details.
Product expiration date, see label for more details.

Sample Requirements

1. Water, serum, plasma, or a whole blood sample will be collected.
2. The sludge and suspended solids in the sample can affect the results obtained from the experiment and should be removed by centrifugal force.
3. Effects of Heparin, EDTA and Sodium Citrate
4. The water will be collected by professional medical personnel. It pointed out that the detection of plasma levels should be a special consideration. In an emergency or special situation, a patient's entire blood sample can also be used for a quick examination.
5. Serum and plasma samples should not be stored at room temperature for more than eight hours, but you should keep them for the next five days. All blood samples must not exceed 48 hours cryogenic freezing.

Test Method

Read the instructions carefully before testing. Please recall all chemicals at room temperature before testing and test at room temperature.

1. Take the test card from the bag packaging and use it within an hour.
2. The whole serum or plasma or whole blood sample is dripped into the hole of the test card and then dripped to approximately 60μL sample buffer start time.
3. weight at room temperature and read the result Read the result incorrectly after twenty minutes.

Interpretation of Test Results

Figure for judging test card results:
1. Incorrect result, no reaction on line C, test is invalid and should be repeated.
2. Negative result, line T shows a red bar greater than or equal to control line C and line R.
3. Positive results: The T-line or T-line does not have a red band, but its color appears lower than the control line C and the control line.

Limitation of Test Method

1.This kit is a qualitative test and is only used for in vitro diagnostic support.
2. Make sure that the correct number of samples is added for testing. Too large or too small a sample may lead to inaccurate results.
3. Hemolysis, lipidemia, jaundice, and contaminated specimens may affect test results, so avoid these specimens.
4. Test results for this reagent are for clinical use 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: Interference with the following types of antibodies was assessed with the reagents and the results showed that there was no cross-reaction.

1.2 Interfering Substances: The following substances were added to the samples at specific concentrations and assessed for their potential interference with the design of the novel coronavirus neutralizing antibody test (2019-nCoV). The results show that different interfering substances will not interfere with the detection results of this reagent.

2. Clinical studies: Using the new Coronavirus (2019-nCoV) IgG Antibody Detection Reagent (colloidal gold method) as contrast reagent, 120 positive and 300 negative samples were selected for detection, respectively, and the results were summarized as follows:

Precautions

1. This product is for in vitro diagnostic use only.
2. This product is disposable and cannot be recycled after use.
3. Before the operation, carefully read the instruction manual and perform the experimental operation in accordance with the reagent instruction manual.
4. Avoid harsh environments (such as environments containing high concentration corrosive gases and dust, such as disinfectant, sodium hypochlorite, acid, alkali, or acetaldehyde). After the experiment is completed, laboratory disinfection should be performed.
5. All specimens and used reagents should be handled as potentially infectious and should be disposed of in accordance with local regulations in case of rejection.
6. Please use the reagent within the expiry date marked on the outer carton, and use the test card as soon as possible after removing it from the aluminum foil bag to prevent moisture.

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

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