Human Novel Coronavirus Nucleoprotein(N) / Spike Glycoprotein(S)

Antibody Immunochromatography Assay Kit

Catalog Number: MBS7135927

For the qualitative determination of human novel coronavirus nucleoprotein(N) / spike

glycoprotein(S) antibody concentrations in serum, plasma and whole blood.

This package insert must be read in its entirety before using this product.

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Principle of The Assay

This product adopts colloidal gold immunity technology, the gol d marker of recombinant novel coronavirus
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nucleoprotein(N) / spike glycoprotein(S) antigen and control antibody was sprayed on t he binding pad; The
nitrocellulosic membrane is coated with two test lines (G and M) and a control line (C). The M-line was coated
with mouse anti-human IgM monoclonal antibody, which was used to detect the novel coronavirus
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nucleoprotein(N) / s pike glycoprotein(S) ant ibody; T he G -line w as c oated w ith mouse a nti-human I gG
monoclonal antibody, which is used to detect the novel coronavirus nucleoprotein(N) / spike glycoprotein(S)
IgG antibody. The C-line was coated with a quality control antibody. When the novel coronavirus
nucleoprotein(N) / spike glycoprotein(S) sample is added to the sample hole of the test card, the sample will
move along the test card under the action of chromatography. If the sample contains the novel coronavirus
nucleoprotein(N) / spike glycoprotein(S) IgM antibody, the antibody binds to the gold-labeled virus antigen.
The immune complex forms a sandwich complex with the coated mouse anti-human IgM m onoclonal
antibody at t he M l ine, s howing a pur plish r ed M l ine, i ndicating a pos itive I gM ant ibody f or t he nov el
coronavirus. I f t he sample c ontains t he novel co ronavirus nucleoprotein(N) / s pike g lycoprotein(S) IgG
antibody, they bind to the gold-labeled novel coronavirus nucleoprotein(N) / spike glycoprotein(S) antigen.
The i mmune c omplex f orms a s andwich c omplex at t he G l ine w ith t he c oated mouse ant i-human I gG
monoclonal antibody, showing a purplish red G line, indicating that the novel coronavirus nucleoprotein(N) /
spike glycoprotein(S) IgG antibody is positive. If the test line G and M do not produce color, the negative
result is displayed. The test card also contains a control line C. The purplish red control line C should be
present regardless of whether there is a test line. If the control line C does not appear, it indicates that the test
result is invalid, and the sample should be tested again.

FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES.

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Main Components

(1) Test card: the test card consists of a plastic card and a test strip. The test strip consists of a nitrocellulose
membrane (the detection area is coated with mouse anti-human IgG and mouse anti-human IgM antibody,
and t he control area i s coated with rabbit anti-chicken I gY), and the b inding pad (sprayed with c olloidal
gold-labeled r ecombinant nov el c oronavirus n ucleoprotein(N) / s pike g lycoprotein(S) ant igen and c hicken
IgY), sample pad, absorbent paper , and PVC soleplate.
(2) Buffer solution: 450μL each, containing phosphate buffer solution (pH6.5-8.0)
(3) Desiccant: a bag containing silica
Note: The components in different batches of kits can't be used interchangeably.

Storage And Validity

Store the test kit at 2℃-30℃, with a v alid period of 6 months. Test strip should be us ed within 20 minutes
once the foil pouch is opened. The date of manufacture and expiry date are shown on the label.

Sample Requirement

1. Apply to serum or EDTA, heparin and sodium citrate anticoagulant plasma/whole blood samples.

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2. The samples should be shaken up and down 5-10 times immediately after collection, and should not be
shaken with force.

-20℃ for 3 months.

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3. The samples should be detected immediately after collection. If they cannot be detected timely, they
should be stored at l ow temperature; The samples can be s tored at 2-8℃ for 48 ho urs, and frozen at

4. Samples with severe lipemia, hemolysis, and microbial contamination cannot be used for the detection of
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this product; Turbid samples affect the determination results of this product.

Detection Procedures
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1. If reagents ar e s tored in a refrigerator at 2-8 °C, take out the reagent c ard and equi librate at r oom
temperature for 30min.
2. Open the aluminum foil bag of the test card, take out the test card and place it on the table horizontally.
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3. Use a pipette to aspirate 10μL of the serum, plasma, or 20μL of the whole blood into the sample hole ,
then use the same method to add 60μL buffer into the sample hole of the test card too.
4. Read the result within 15 minutes, and the results read after 18min are invalid.
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Interpretation of Result

1) Positive r esults: Both the test line (G) and the control line (C) show c olor bands, i ndicating t hat I gG
antibody of the novel coronavirus nucleoprotein(N) / spike glycoprotein(S) is positive; Both the test line (M)
and t he c ontrol line ( C) s how c olor ba nds, indicating t hat t he n ovel c oronavirus nuc leoprotein(N) / s pike
glycoprotein(S) IgM antibody is positive. The test line (M), (G) and control line (C) all show color bands,
indicating that the novel coronavirus nucleoprotein(N) / spike glycoprotein(S) IgM and IgG antibodies are
positive. As shown in the figure.

Control line(C) Control line(C) Control line(C)

Test line (G)
Test line (M) Test line (G) Test line (M)

FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES.

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2) Negative result: If only the control line C develops color and neither the G nor M detection lines develop
color, no IgM/IgG antibody of novel coronavirus nucleoprotein(N) / spike glycoprotein(S) is detected, and the
result is negative. As shown in the figure.

Control line(C)

3) Invalid result: No band appears on t he control line (C), and it is judged as an i nvalid result regardless of
whether the detection line (G) (M) shows a band. As shown in the figure.

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Control line (C) Control line (C) Control line (C)
Test line (G) Test line (G)
Test line (M) Test line (M) Test line (M)
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Limitation
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1. FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES.

2. The kit is only for the detection of human serum, plasma and whole blood samples.
3. The test results may be wrong due to technical reasons, operational errors and other sample factors.
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Precautions

1. Equilibrate the sample diluent and test card to room temperature (more than 30min) before testing.
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2. The test should be performed strictly in accordance with the instructions.

3. The result must be interpreted at 15min, and the result read after 18min is invalid.
4. Do not use repeated freeze-thaw, highly hemolyzed and lipemia samples.
5. This product contains animal-derived substances. Although it is not contagious, it should be treated with
care as a pot ential source of infection when handling it. Users should take precautions to ensure their
safety and that of others. After the test is completed, the used test cards, sample diluents, and straws,
etc. are treated as biomedical waste.
6. This product i s a s ingle-use reagent. D o not reuse i t. It i s onl y used for research. Do not use expired
products.
7. Do not use a kit with obvious damage and damaged test card in the package.
8. There is desiccant in the aluminum foil bag, not to be taken orally.

FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES.

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