Span Biotech Ltd.

【Name】

Testing kit for New coronavirus (2019-nCOV) IgG/IgM antibody Rapid Test WB/S/P

【Specifications】

25 tests

【Introduce】

This kit uses the colloidal gold immunochromatographic principle to qualitatively detect novel coronavirus igg/igm antibodies in human serum, plasma, or whole blood. the sample to be tested was added to the sample hole of the test paper, and then added 2 drops of sample diluent. the igg/igm antibody in the sample combined with the recombinant new coronavirus antigen labeled with the colloidal gold on the binding pad formed complex. under the action of chromatography, it diffused forward along the nitrocellulose membrane (nc membrane). the nitrocellulose membrane was fixed with two detection lines (g line, m line) and one quality control line (c line). the g line was fixed with anti-human igg antibody for the detection of new coronavirus igg antibody; the m line was fixed with anti-human igm antibody for the detection of new coronavirus igm antibody; and the c line had quality control for the detection of the new coronavirus ig antibody.

If the sample contains a new coronavirus IgG antibody, then the antibody binds to the recombinant new coronavirus antigen labeled with colloidal gold, diffuses forward, and then binds to the anti-human IgG antibody fixed on the NC membrane detection line (G line). if the sample contains a novel coronavirus igm antibody, then the antibody binds to the recombinant new coronavirus antigen labeled with colloidal gold, diffuses forward, and then binds to the anti-human igm antibody fixed on the nc membrane detection line (m line). The darker the color of the colloidal gold accumulated on the detection line, the higher the concentration of the new coronavirus antibody in the sample. To monitor the effectiveness of the test card, set up a quality control line (line C), whether there is a detection line (line T), quality control line (line C) should be color, otherwise the test results are judged invalid.

【Storage】

Stored at 4 to 30°c and valid for 18 months.

After the aluminum foil bag is unsealed, please use it as soon as possible.

【Sample】

1. It is suitable for human serum, plasma and whole blood samples.

2. The samples should be used as soon as possible; if they cannot be used immediately, the serum / plasma samples should be kept at 2-8°C for 5 days and -20°C for long-term preservation; the whole blood samples should be placed at 2-8°C to avoid hemolysis;

3.The sample contains a large amount of lipids, hemolysis or turbidity, do not use, so as not to affect the judgment of the results.

【Testing steps】

Please read the kit instructions carefully before use

1. The samples to be tested and the reagents needed were removed from the storage conditions and balanced to room temperature.

2. Unpack the aluminum foil bag, remove the test card and place it on the horizontal table.

3.Take 10μL sample (serum, plasma or whole blood), add 2 drops (about 60μL) or 60μL sample dilutions to the test card directly;

4. Timing, within 15 minutes to determine the results.

【Explanation of results】

1,Negative : if only the quality control line (line C), the detection line (line G) and (line M) do not show color, indicating that no new coronavirus antibody was detected, the result was negative.

2,positive:

2.1 If the quality control line (line C) and the detection line (line M) are colored, the new coronavirus IgM antibody is detected, and the result is positive for IgM antibody

2.2 If the quality control line (line C) and the detection line (line G) show color, the new coronavirus IgG antibody was detected and the result was positive for IgG antibody.

2.3 If the quality control line (c line) and the detection line (g line) and (m line) are colored, the new coronavirus igg and igm antibodies are detected, and the results are judged to be positive for igm antibodies and igg antibodies.

3,Invalid :If there is no quality control line (line C), regardless of whether the detection line (line G) and (line M) color, the detection is invalid.

【matters need attention】

1. This kit is for in vitro diagnosis only.

2. The determination of the results shall be completed within 15 minutes after the addition of the sample, and the measurement results over 15 minutes shall be invalid.

3. Please balance the sample and related reagents at room temperature before use. In order to prevent the test card from getting damp, finish the use within 30 minutes after unsealing.

4. the use of non-reagent-matching sample dilutions is prohibited.

5. When the dropper is used to add the sample, the first 1 to 2 drops of sample solution are discarded, and then the vertical sample is added to avoid the bubble at the end of the sample.