OEM ODM Covid Neutralizing Antibody Test Kit For Covid-19

Sample Requirements

1.Collect serum, plasma, or whole blood samples.
2.The precipitates and floats in the sample affect the experimental results, so they must be removed by centrifugation.
3.Use of anticoagulant: jellyfish skin, EDTA, sodium citrate anticoagulant has little effect.
4.Blood sampling should be done by a medical specialist. Serum / plasma test is the first choice. In case of emergency or special circumstances, you can perform rapid inspection using the whole blood sample of the patient.
5.Storage time of serum and plasma samples should not exceed 8 hours at room temperature. 2 ° C-8 ° Within 6 months, 5 days ° You can save it in C, but do not repeat the freeze thaw cycle. The freezing time of all blood samples must be 48 hours to 8 degrees Celsius.

Test Method

Read the instructions carefully before testing. Return all reagents to room temperature before the test. Examinations should be performed at room temperature.
1. Take the test card from the packaged reagent bag and use it within 1 hour.
2. Test well loading well μ Add a sample of L (serum, plasma, or whole blood) and then μ Add a sample buffer and start timing.
3. The result will be disabled after 20 minutes.

Interpretation of Test Results

Interpretation of test cards
1. Invalid results: the quality control line (C line) is invalid because there is no reaction line, and you need to do the test again.
2.Negative results: the red band appears in the test line (t line), the color rendering performance is the standard line (r line), the quality control line (C line) and the reference line (r line).
3.Positive results: the red band is not displayed on the test line (t line), and the red band of the test line (t line) is color coded from the reference line (r line) and the quality control line (C line), and the reference line (r line) is color coded.

Limitation of Test Method

This element is only used for in vitro diagnosis.
2. If the sample is too many or too small, the result is false.
3. Hemolysis, blood lipids, jaundice, and contaminated samples should be affected because they may affect the test results.
4.The results of a reagent test are for clinical reference and cannot be used as the sole basis for clinical diagnosis and treatment. The final diagnosis of the disease should be based on a comprehensive assessment of all clinical and laboratory results.

Product Performance Indicators

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1. Specificity analysis
1.1 cross reaction: the following types of antibody evaluation were conducted for interference with reagents, and no cross reaction occurred.

1.2 interfering substances: in New Coronavirus (2019 ncov) neutralizing antibody test items, the potential interference of the following substances is assessed by adding the following substances in a specific concentration sample. The results show that all kinds of interfering substances will not interfere with the detection results of reagents.

2.Clinical study: 120% positive and 300 negative samples were selected from Novell coronavirus (2019 nCoV) IgG test reagents (colloidal gold method) as controls. The results are summarized below.

Precautions

This product is only used for in vitro diagnosis.
Cannot be used after disposal.
3. Before you begin, read the operation guide carefully and follow the reagent guide.
4. Disinfectant, sodium hypochlorite, acid-base, acetaldehyde, other corrosive gas, and environment in a harsh environment. After experimentation, it is necessary to disinfect in the laboratory.
5. All samples and reagents used are potentially potentially contagious and must be destroyed according to local regulations.
6. The reagent must be used within the validity period listed in the outer package. Use the guidance card as soon as possible to remove the card from the aluminum foil bag and prevent moisture.

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.