Biosensor Coronavirus Neutralizing Antibody Rapid Test 2C - 30C Storage

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. Precipitates and floats in the sample affect the experimental results and must be removed by centrifugation.
3. Anticoagulants: Jellyfish skin, EDTA, sodium citrate The use of anticoagulants has little effect.
4. Blood sampling should be done by a medical professional. Serum / plasma testing is the first choice. In case of emergency or special circumstances, the patient's whole blood sample can be used for rapid examination.
5. The storage time of serum and plasma samples should not exceed 8 hours at room temperature. It can be stored in 2 ° C ~ 8 ° C 6 months, 5 days or less, ~ 20 ° C, but repeated freeze-thaw cycles should be avoided. Freezing time of whole blood sample should not be less than 48 hours ℃ -8 ℃.

Test Method

Please read the guide carefully before the exam. Please lower all tested drugs to room temperature before testing. The test shall be conducted at room temperature.
1. Remove the test card from the packaged test bag and use it within 1 hour.
2. 20 μ Add l sample (serum, plasma or whole blood) into the filling hole of the test card, and then drop 2 drops (about 60 drops) μ l) Add sample buffer and start timing.
3. The reaction time was 10-15 minutes at room temperature. The result was invalid after 20 minutes.

Interpretation of Test Results

Result judgment chart of test card:
1. Invalid results: the quality management line (C line) has no response line, the test is invalid, and the experiment needs to be carried out again.
2. Negative results: the detection line (t line) appeared red band, and its color rendering was higher than that of control line (r line), quality management line (C line) and control line (r line).
3. Positive results: the test line (t line) had no red band, or the test line (t line) had red band, but the color development was lower than that of the control line (r line), and the quality was decreased. Control line (C line) and control line (r line).

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 sample. Too many or too few samples will lead to incorrect results.
3. Hemolysis, blood lipid, jaundice and contaminated samples may affect the test results and should be avoided.
4. Reagent test results are only for clinical reference, can not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease must be based on a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

​

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

1. This product is used only for in vitro diagnosis.

This product cannot be used after it is thrown away.

3. Before you start, read the operating guide carefully and follow the reagent guide to perform the experiment.

4. Do not conduct experiments in harsh environments such as disinfectants, sodium hypochlorite, acid-base, acetaldehyde, other corrosive gases, and dusty environments. After the experiment, it must be disinfected in the laboratory.

5. All samples and reagents used are considered potentially contagious substances and should be destroyed according to local regulations.

6. Reagents must be used within the shelf life marked on the outer package. Use the induction card as soon as possible to remove it from the aluminum foil bag and 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.