Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. The sediment and floating matter of the sample will affect the experimental results and should be removed by centrifugation.
3. Anticoagulant: the use of jellyfish skin, EDTA and sodium citrate anticoagulant has little effect.
4. Blood collection needs medical experts to complete. Serum / plasma test is preferred. In case of emergency or special circumstances, whole blood samples of patients can be used for rapid examination.
5. Serum and plasma samples should not be stored at room temperature for more than 8 hours. It can be stored for 6 months at 2 ℃ ~ 8 ℃ for 5 days and below - 20 ℃, but repeated freezing thawing cycles should be avoided. The whole blood samples should not be frozen at 2 ℃ ~ 8 ℃ for less than 48 hours.

Test Method

Please read the guide carefully before the test. Please reduce all the test drugs to room temperature before testing. The test should be carried out at room temperature.
1. Take out the test card from the packaged test bag and use it within 1 hour.
2. 20 μ L add the sample (serum, plasma or whole blood) to the filling hole of the test card, and then drop 2 drops (about 60 drops) μ l) Add sample buffer and start timing.
3. React at room temperature for 10 ~ 15 minutes and read the results. The results were invalid after 20 minutes.

Interpretation of Test Results

Test card result judgment chart:
1. Invalid results: there is no response line in the quality management line (line C), the test is invalid, and the experiment needs to be carried out again.
2. Negative results: the test line (line T) appears red band, and the color rendering is higher than the control line (line R), quality management line (line C) and control line (line R).
3. Positive results: the test line (line T) has no red band, or the test line (line T) has red band, but the color rendering is lower than the control line (line R), and the quality is decreased. Control line (line C) and control line (line R).

Limitation of Test Method

This element is only used for in vitro diagnosis.
2. In order to test, it is necessary to add an appropriate amount of samples. Too many or too few samples can lead to incorrect results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may affect the test results and should be avoided.
4. The test results of the reagent are only for clinical reference and can not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease must be carried out after comprehensive evaluation 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 the new coronavirus (2019 ncov) neutralizing antibody test project, the potential interference of the following substances was evaluated by adding the following substances to the specific concentration samples. The results showed that all kinds of interfering substances would not interfere with the detection results of the reagent.

2. Clinical research: 120 positive samples and 300 negative samples were selected from Novell coronavirus (2019 ncov) IgG test reagent (colloidal gold method) as contrast agent. The results are summarized as follows.

Precautions

1. This product is only used for in vitro diagnosis.
2. This product is disposable and cannot be reused after use.
3. Please read the operation guide carefully before starting, and carry out the experiment according to the reagent guide.
4. Do not carry out experiments in harsh environment (such as 84 disinfectant, sodium hypochlorite, acid-base or acetaldehyde and other corrosive gases and dusty environment). The laboratory should be disinfected after the experiment.
5. All samples and reagents used should be considered as potential infectious substances and destroyed according to local regulations.
6. The reagent must be used within the validity period marked on the external package. The sensor card should be used as soon as possible after it is removed from the aluminum foil bag to 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.