Novel Coronavirus (COVID-19)IgG/IgM Antibody Test kit (Colloidal Gold) (For professional use)
A novel coronavirus (COVID-19) IgG/IgM antibody test kit (colloidal gold)
[ Package Type]
25 tests/ box
This product is used for the qualitative detection of SARS-CoV-2 (COVID-19) IgM and IgG Antibodies in human serum, plasma, whole blood or fingertip blood.
This kit is a colloidal gold immunochromatographic testing product for the qualitative determination of IgM and IgG antibodies against novel coronavirus (COVID-19)
in human serum, plasma, whole blood or fingertip blood. Antibody-antigen sandwich one-step assay has been used in this detection. For the test line (M line and G line),
colloidal gold conjugated COVID-19 antigen is used as a detector and coated on the conjugate pad, and mouse anti-human IgM antibody and mouse anti-human IgG
antibody are used as the two captures and coated separately on nitrocellulose membrane. For the quality control line (C line), colloidal gold conjugated rabbit IgG
is used as a detector and coated on the conjugate pad and goat anti-rabbit IgG antibody is used as the capture and coated on nitrocellulose membrane. When a sample is
loaded on the conjugate pad, the IgM or IgG antibody against the virus antigen in the sample specifically binds to the virus antigen that is conjugated with gold, forms an
IgM or IgG antibody-antigen gold complex, then the complex migrates on the nitrocellulose membrane and is captured by mouse anti-human IgM or IgG antibody and
immobilized on the nitrocellulose membrane, and then red bands appear on the detection line (M line and G line). The gold labeled rabbit IgG is captured by goat anti rabbit IgG
antibody and forms a red quality control line (C line) on the nitrocellulose membrane at the same time.
Each kit includes one test card which is packed in aluminum foil bag and one dilution buffer bottle. The test card comprises plastic card and reagent strip. The reagent strip comprises PVC pad, sample pad, conjugate pad, nitrocellulose membrane and absorbent pad.
[Storage and validity]
The kit shall be stored at 4℃ - 30℃, with a validity period of 12 months. After the aluminum foil bag is opened, it should be used within 15 minutes.
1. The sample can be whole blood or serum, plasma. The anticoagulants used for plasma collection could be sodium citrate, EDTA.2Na or heparin. Venous blood or fingertip blood should be collected in sterile condition.
2. The sample should be tested immediately after collection.
3. If immediately testing is not available, the sample can be stored at 2-8℃ for 48 hours and -20℃ for 3 months. While in the testing, the samples need to be restored to room
temperature at 10-30 ℃ before loading.
1. Read the instruction carefully before using the test kit, and restore the test kit and sample to room temperature.
2. Take out the test card from the foil bag, put it on the level table and mark it;
3. Add 10μl serum or plasma sample or 20ul(About 1 drop) whole blood sample to sample well of the card with dispette, then add 80μl (about 2-3 drop) dilution buffer, start timing;
4. Wait for 1-15 minutes until the test line appear as red and record the result, the maximum time is 15 minutes, or else record as a negative if test line does not appear as red at 15
[Interpretation of test results]
Positive：C line appears red, G line appears red, M line appears red, which indicates the IgM and IgG antibodies against novel coronavirus in the sample are detected; C
line appears red, G line appears red, M line does not appear red, which indicates the IgG antibody against novel coronavirus in the sample is detected; C line appears red,
M line appears red, G line does not appear red, which indicates the IgM antibody against novel coronavirus in the sample is detected.
Negative: C line appears red, G line does not appears red, M line does not appear red, which indicates both the IgM and IgG antibodies against novel coronavirus in the sample
are not detected.
Invalid：C line does not appear red.
Tests evaluated by an independent clinical laboratory showed that Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Kit (Colloidal Gold) gave 91.4% of sensitivity and 97.1% of specificity compared to fluorescence RT-PCR assay.
[Limitations of the examination procedure]
Due to customs check,so we use simple box to pass customs check,so thebox what you get maybe not same as photo,but it is same product,and same function,don't worry.
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