Intended Use:
To test the 2019-nCoV antibody in serum, whole blood and plasma
Sample Requirements:
The samples should be serum, whole blood and plasma or those stored at 2℃ - 8℃ for no more than one week.
Principle:
With the 2019-nCoV protein as antigen solid-phase nitrocellulose membrane, the principle of percolation-type indirect method is adopted to detect the 2019-nCoV antibody in serum, whole blood and plasma.
Compositions:
1. Reaction plate, 20 Tests 2. Buffer 3. Sample tube
Test Method:
1. Take out the reaction plate, buffer and sample to be tested, and then balance them to room temperature (18°C - 25°C);
2. Unpack the aluminum foil package of the reaction plate, and place the reaction plate on the balance surface;
3. Collect fingertip blood with a blood sampling needle, or take 20 μL whole blood/10 μL plasma with a pipette, and then drop it into the sample well of the reaction plate for complete penetration;
4. Then add 100 μL sample buffer to the sample well of the reaction plate;
5. Observe the results after 15 minutes
Limitations of the Test Method:
1. This reagent test is only used to detect 2019-nCoV antibody, but not to directly detect the content of 2019-nCoV. For diagnosis of patients, comprehensive analysis shall be conducted by combining the test results with clinical signs and symptoms.
2. For the serum, whole blood and plasma samples with low antibody content, the 2019-nCoV antibody may be not detected. Part of the patients with novel coronavirus pneumonia do not produce antibodies or only produce a small number of antibodies. In such cases, a negative result may appear.
3. When the test result is suspicious, multiple other tests should be also performed to confirm the diagnosis.
Precautions:
1. The Product Registration Certificate No. has not been obtained for this product. It is only for research, and not for clinical diagnosis.
2. Once the test is started, it shall be carried out continuously according to the operation steps until the end.
3. After the kit is taken out from the refrigerator, the reagent shall be restored to room temperature.
