Novel Coronavirus (2019-nCoV) Antibody Test Kit (Colloidal Gold Assay)

 Intended Use:

To test the 2019-nCoV antibody in serum

Sample Requirements: 

The samples should be fresh blood and serum 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.

Compositions:

1. Reaction plate, 20 Tests 2. Reagent I, 1 bottle of buffer 3. Sample tube

Test Method:

1. Take out the test card, 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 test card, and place the test card 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 test card;

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 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.