Storage: The product shall be stored at 2℃ - 8℃, and shall not be frozen in storage; with a validity period of 12 months

Application details:

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.

Product description:

Positive:

(1) If C line on reaction plate is blue and IgM test line is red, it indicates that the 2019-nCoV antibody is positive. This kind of antibody appears at an early stage, which can be positive in the very early stage (3-7 days), and can be used for screening suspected 2019-nCoV cases at an early stage.

(2) If C line on reaction plate is blue and IgG test line is red, it indicates that the 2019-nCoV antibody is positive. This kind of antibody appears at a mid or advanced stage. The positive result indicates that the patient is in convalescence or has past infection, which can be used for disease course monitoring and retrospective diagnosis for 2019-nCoV patients.

Negative:

If C line on reaction plate is blue, while both IgM test line and IgG test line do not show red, it indicates that 2019-nCoV antibody is negative.

Invalid:

If C line on reaction plate does not show blue, the test kit is invalid no matter IgM test line and IgG test line are red or not.