Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. The sediments and suspensions in the reagents have an impact on the experimental results and are removed by centrifugal separation.
3. Anticoagulant: heparin, EDTA, sodium citrate anticoagulant have no effect.
4. Blood collection should be done by professional medical personnel. It is recommended to give priority to serum and blood sample examinations. In emergency or special circumstances, the patient's whole blood sample can also be used for rapid testing.
5. Serum and plasma reagents should not be stored at room temperature for more than 8 hours. These 2 days can be stored for 5 days, the temperature reaches ℃ 8 ℃, and then the temperature reaches ℃ in the next 6 months, but repeated freezing and thawing cycles must be avoided. The whole blood sample cannot be frozen, and the temperature is 2℃~8℃ for more than 48 hours.

Test Method

Please read the instructions carefully before taking the exam. Please test all the reagents at room temperature to room temperature, and test at room temperature.
1. Take out the test card from the packaged reagent bag and use it within 1 hour.
2. Add L of the sample (serum, plasma or whole blood) in the loading well of the μ test card, followed by the start timing of adding 2 drops (approximately 60 drops of μL) of sample buffer.
3. Observe the result of the reaction for 10 to 15 minutes at room temperature. The result is invalid after 20 minutes.

Interpretation of Test Results

Explanation of the test card
1. Invalid result: The quality management line (line C) is invalid because there is no response line, and you need to retest.
2. Negative results: the red band is displayed on the test line (T line), and the color rendering is represented by the standard line (R line), the quality management line (C line) and the reference line (R line).
3. Affirmative result: display the red band on the test line (T line), color-code the red band of the test line (T line) from the reference line (R line) and the quality management line (C line), and put the reference line ( R line) coloring.

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

​

1. Specificity analysis

1.1 Cross-reaction: Due to the interference of reagents, the following types of antibodies were evaluated, and no cross-reactions occurred as a result.

1.2 Interfering substances: In the new coronavirus (2019ncov) neutralizing antibody test project, the potential interference of the following substances is evaluated by adding the following substances to a sample of a specific concentration. All kinds of interfering substances will not interfere with the test results of the reagents.

2.Clinical research: Use the 2019 ncov igg ab test reagents (colloidal gold method) that have been on the market as comparison reagents, and select 120 positive reagents and 300 negative reagents as tests. The results are summarized as follows.

Precautions

1. This product is only used for biological in vitro diagnosis.
2. It cannot be used after being voided.
3. Before starting, please read the operating instructions carefully and follow the reagent instructions.
4. Disinfectant, sodium hypochlorite, acid and alkali solution, acetaldehyde, other corrosive gases and environment in harsh environment. After the experiment, it needs to be disinfected in the laboratory.
5. All samples and reagents used are potentially infectious and must be destroyed in accordance with local regulations.
6. Reagents must be used within the validity period indicated on the outer packaging. Remove the card from the aluminum foil bag to prevent moisture.

Company profile

---

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.