Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit (Colloidal Gold Immune-Chromatography)

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Product Name：Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit (Colloidal Gold Immune-Chromatography)

Intended Use：To evaluate the level of neutralizing antibodies in humans after being vaccinated with 2019-nCoV vaccine and recovering from infection.

Main Components：

Type A

1. Detection kit for one person, 2. One Specification, 3. One bottle of diluent    , 4. Colorimetric card.

Type B

1. Detection kit for one person, 2. One Specification, 3. One bottle of diluent , 4. Colorimetric card, 5. Dropper, 6. Blood sampling needle, 7. Cotton swab, 8. Alcohol pad.

Main Components

accessories

reagent strips

all item

Clinical performance: The detection reagent was compared with the neutralization test with the positive judgment value of NT50 of 30 in 350 cases, including pre-immunization, post-immunization and convalescent serum tests. Compared with a neutralization titer greater than 30, the relative sensitivity was 96.7% (95% CI 92.0% - 92.8%), the relative specificity was 97.9% (95% CI 97.90% - 99.4%), and the total coincidence rate was 97.4%.

Detection method:

Note: Please read instruction manual of this test reagent carefully before all operations.

1．Equilibrate the sample (whole blood, serum, plasma) and diluent to room temperature.

2．Mark the sample number and remove the outer package of the test reagent (note: the test reagent without the outer package should be used within 1 hour, and it should be used immediately when the room temperature exceeds 30℃ or in high humidity environment)

3．Peripheral blood sample

    1）Tear off disposable alcohol tablets, wipe fingertips and dry naturally.

   2）Open the cap of the blood sampling needle, press it to the sterilized  fingertip, and needling the fingertip.

   3）Squeeze out the first drop of blood and wipe it off with a cotton swab.

  4）Squeeze out the second drop of blood, take 10-20 μL into the sample hole, add 80 μL diluent (3 drops), and press with cotton swab to stop bleeding.

    5）After 15 minutes of reaction, the result gets invalid after 30 minutes.

4. Serum or plasma: Take 5-10 μL sample (1 drop), add it into the sample hole, add 80 μL diluent (3 drops), react for 15 minutes, and the result gets invalid after 30  minutes.

5. Venous whole blood: Take 10-20 μL sample (1 drop), add into the sample hole, add 80 μL diluent (3 drops), react for 15 minutes, the result gets invalid after 30 minutes.

Explanation for the results:

1．Positive：Two purplish red bands in the T line and C line area in the observation window, indicating that the 2019-nCoV neutralizing antibody in the sample is positive.

2．Negative：One purplish red band in the C line area in the observation window, no band in the T line area, indicating that the 2019-nCoV neutralizing antibody in the sample is negative.

Invalid：No purplish red band in the C line, with or no band in the T line, indicating that the test is invalid.

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仇纯荣（Angela Qiu）：13581890639

赵可（Chris）：15911020280