COVID-19 Neutralizing Antibody Rapid Test Standard Q Antigen Test

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. Sediments and suspended solids in the sample may affect the experimental results and should be removed by centrifugation.
3. Anticoagulant: Heparin, EDTA, sodium citrate are ineffective.
4. Venipuncture is performed by a professional medical staff. We recommend that you give priority to serum / plasma tests. In emergencies and special cases, a patient's entire blood sample can also be used for rapid testing.
5. The storage time of serum and plasma samples at room temperature should not exceed 8 hours. They are
It can be stored at 2 ° C to 8 ° C for 5 days and below -20 ° C for 6 months, but avoid repeated freeze-thaw cycles. Whole blood samples should not be stored frozen at 2 ° C-8 ° C within 48 hours.

Test Method

Please read the instructions carefully before testing. Allow all reagents to cool to room temperature before testing. The test is conducted at room temperature.
1. Remove the test card from the packaged reagent bag and use it within 1 hour.
2. Add 20 μL of sample (whole serum and plasma), add 2 drops of sample buffer (about 60 μL), and start the clock.
3. After reacting at room temperature for 10 to 15 minutes, read the results. After 20 minutes, the result was invalid.

Interpretation of Test Results

Figure to judge the result of the test card:
1. Invalid result: Quality control line (c line) has no reaction line, is invalid and needs to be retested.
2. Negative result: A red band appears on the test line (T line) and the color is higher than or equal to the reference line (R line), and the color is on the quality control line (C line) and the reference line (R line). arrive.
3. Positive result: The test line (T line) has no red band and is smaller than the reference line (R line), and the control line (C line) and reference line (R line) are colored.

Limitation of Test Method

1. This kit is used for qualitative tests and is used only for in-vitro assisted diagnosis.
2. Make sure to add the appropriate amount of sample and perform the test. If the sample size is too large or too small, the results may be incorrect.
3. Hemolysis, blood fats, jaundice, and contaminated samples should be avoided as they can affect test results.
4. The test results of this reagent are for clinical reference only and cannot be the sole basis for clinical diagnosis and treatment. The final diagnosis should be a combination of evaluation and laboratory results from all clinical trials.

Product Performance Indicators

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1. Analysis of specificity
1.1 1.1 Cross-reactivity: As a result of evaluating the following types of antibody interfering reagents, there was no cross-reactivity.

1.2 Interfering Substances: The following substances are added to the sample at specific concentrations to assess potential interference in the 2019 nCoV and Ab test items. As a result, none of the interfering substances interfered with the detection of the reagent.

2. Clinical study: Using the above 2019 NCOVIGAB detection reagent (colloidal gold method) as a comparative reagent, 120 positive samples and 300 negative samples are selected and tested. The research results can be summarized as follows.

Precautions

1. This product is used only for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Read the instructions carefully before starting work and perform the experimental work according to the reagent instructions.
4. Avoid inspections under harsh environmental conditions (including 84 disinfectants, sodium hypochlorite, alkali or acetaldehyde, high concentration corrosive gases such as dust). After the experiment is over, disinfect the laboratory.
5. All samples and reagents used are considered potential contagious substances and should be disposed of in accordance with local laws and regulations.
6. Reagents should be used within the shelf life indicated on the package. Use a test card as soon as you remove it from the aluminum foil bag to prevent moisture.

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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.

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