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Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Test

Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Test

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  • Product description
  • Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Test (Colloidal Gold)

    【PRODUCT NAME】

    Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Colloidal Gold)

    【SPECIFICATIONS】

    5 test cards/ box,20 test cards/ box, 40 test cards/ box

    【INTENDED USE】

    This kit is used for in-vitro semi-quantitative determination of novel coronavirus neutralizing antibodies in human serum, plasma, venous whole blood or peripheral whole blood.
    The novel coronavirus neutralizing antibodies are protective antibody produce by the human body after inoculation with novel coronavirus vaccine or infection with novel coronavirus. The kit is used to monitor the presence of neutralizing antibodies in subjects vaccinated with the novel coronavirus vaccine or in people infected with the novel coronavirus, it can be used to evaluate the immune effect after vaccination or whether neutralizing antibodies are produced in human body after infection with novel coronavirus.
    For professional use only.

    【Main components】
    Type A:
    1. SARS-CoV-2 NAbs Test Cassette;
    2. Sample Diluent; 
    3. Lancet; 
    4. Alcohol Pad; 
    5. Colorimetric Card; 
    6. Dropper.
    Type B:
    1. SARS-CoV-2 NAbs Test Cassette; 
    2.Sample Diluent; 
    3. Colorimetric Card; 
    4. Dropper.
    Note: Components of different batches cannot be mixed use.

    【Inspection method】

    1. Place the test cassette, sample diluent and test sample for 15~30 minutes, and equilibrate to room temperature(10~30℃).
    2. Open the aluminum foil pouch of the test cassette, and place the test cassette on a flat surface.
    3. Write sample ID on the plastic case of the test cassette.
    4. Peripheral whole blood samples:
    1) Tear off the disposable alcohol pad, wipe your finger, and dry naturally.
    2)Using the lancet, pull out the lid of the lancet , press it on the finger that has been disinfected, and puncture the finger with the lancet.
    3) Squeeze out the first drop of whole blood and wipe it off with a cotton swab.
    4) Squeeze out the second drop of whole blood. Take 25μL of whole blood sample, add it into the sample well of the test cassette, and add 80μL(approximately 3 drops) of sample diluent. And then use a cotton swab to stop the bleeding.
    5) Incubate for 15 minutes at room temperature. Result got after 30 minutes is invalid.
    5. Serum and plasma samples:
    Take 20μL sample (1 drop with a dropper), add it into the sample well of the test cassette, and add 80μL sample diluent(approximately 3 drops with a dropper). Incubate at 10~30℃ for 15 minutes. Result got after 30 minutes is invalid.
    6. Venous whole blood samples:
    Take 25μL sample (1 drop with a dropper), add it into the sample well of the test cassette, and add 80μL sample diluent(approximately 3 drops with a dropper). Incubate at 10~30℃ for 15 minutes. Result got after 30 minutes is invalid.

    【Interpretation of test results】

    Positive: Two color bands appear in the observation window, that is, a red or magenta line appears at the position of the quality control line (C line) and the detection line (T line) (as shown in result 1), which indicates the test result of novel coronavirus neutralizing antibodies in the sample was positive.
    Negative: A red or magenta line appears at the position of quality control line (C line) in the observation window, and no line appears at the position of the test line (T line)
    (as shown in the result 2), indicating the test results of the novel coronavirus neutralizing antibodies in the sample were negative or the concentration was below the limit of detection of the kit.
    Invalid: No line appears in the position of the quality control line (line C) in the observation window (as shown in result 3), which indicates that the test is invalid, should collect sample again and retest.

     

     

    The results were interpreted using a colorimetric card as follows:

     

     

    1) Color band<1:8 color band: neutralizing antibodies titer less than 1:8, or neutralizing antibodies titer lower than the detection limit of this kit.
    2) Color band between 1:8 color band and 1:64 color band: neutralizing antibodies titer between 1:8~1:64.
    3) Color band>1:64 color band: neutralizing antibodies titer more than 1:64.

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