2019-NCoV Serum Coronavirus Neutralizing Antibody Rapid Test Virus

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. Precipitates and suspended matter in the sample affect the experimental results and must be removed by centrifugation.
3. Anticoagulant: The use of anticoagulants such as jellyfish skin, EDTA and sodium citrate has little effect.
4. Blood collection should be done by a medical professional. Priority is given to serum / plasma tests. In emergencies and special cases, the patient's entire blood sample can be used for rapid testing.
5. The storage time of serum and plasma samples at room temperature should not exceed 8 hours. It can be stored at temperatures between 2 ° C and 8 ° C for 6 months, 5 days or shorter, up to 20 ° C, but repeated freeze-thaw cycles should be avoided. The freezing time of whole blood specimens should be 48 hours to 8 ° C or less.

Test Method

Please read the guide carefully before the exam. Allow all study agents to cool to room temperature before testing. The test should be conducted at room temperature.
1. Remove the test card from the test pack and use it within 1 hour.
Add the sample to the buffer solution (about 2 μl) and add the sample to the buffer solution (about 2 μl).
3. Reaction time at room temperature is 10 to 15 minutes. After 20 minutes, the result was invalid.

Interpretation of Test Results

Result judgment chart of test card:

1. Invalid result: There is no response line on the quality control line (C line). The test is invalid and needs to be re-experimented.
2. Negative result: Red streaks appear on the test line (t line), and the color development rate is higher than that of the control line (r line), quality control line (C line), and control line (r line).
3. Positive result: There is no red belt in the test line (t line), or there is a red belt in the test line (t line), but the color development rate is lower than that of the control line (r line) and the quality is deteriorated. Control line (C line) and control line (r line).

Limitation of Test Method

1. This device is used only for in vitro diagnosis.
2. Appropriate amount of sample must be added to perform the test. Too many or too few samples will result in inaccurate results.
3. Hemolysis, blood fats, jaundice, and contaminated samples can affect test results and should be avoided.
4. Reagent test results are for clinical reference only and cannot be the sole basis for clinical diagnosis and treatment. The final diagnosis of this disease must be based on a comprehensive assessment 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: The new coronavirus (2019 ncov) neutralizing antibody test item evaluates the potential interference of the following substances by adding the following substances to a sample of a specific concentration. As a result, it was clarified that each interfering substance did not interfere with the detection result of the reagent.

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