SARS-CoV-2(COVID-19)IgM/IgG Antibody Fast Detection Kit

IgM/IgG Antibody Fast Detection Kit

China’s professional manufacturer of antibody detection kit.

Whatsapp: (86)13951936338 – Jessie

Email: sales@ownhealthylife.com

Antibody fast detection kit is used for in vitro qualitative detection of IgM and IgG antibodies in human serum, plasma, or whole blood.

[Principle]

This kit adopts a colloidal gold-immunochromatography assay(GICA). When an appropriate amount of sample is added to the sample well of the test card, the sample will move forward along the test card under capillary action. If the sample contains an IgM/IgG antibody of SARS-CoV-2, the antibody will bind to the colloidal gold-labeled SARS-CoV-2 antigen and the immune complex will be captured by the monoclonal anti-human IgM antibody or monoclonal IgG antibody immobilized on the nitrocellulose membrane to form a purple-red Mline or G line, showing that the sample is positive for IgM or IgG antibody.

[Storage]

1. The original packaging should be stored in a dry place at 4-30°C and protected from light. The period of validity is 12 months.
2. After opening the inner package, the test card will become invalid due to moisture absorption, please use it within 1 hour.

[Rapid Test Cassette Kits Test Procedure]

1. Open the ampoule containing the sample diluent(break the top of the ampoule) and put it aside securely.
2. Wipe the blood collection part with an alcohol swab (wet) and let it dry naturally.
3. Use a sterile peripheral blood collector to pierce 2-3 mm from the abdomen of the fingertip.
4. Take 20ul (about 1 drop) of blood with a disposable plastic dropper.
5. Add 20ul of blood into sample diluent. Aspirate and blow-out with the dropper for 5 times to mix evenly.
6. Use the plastic dropper to aspirate 50ul (about 2-3 drops) of the mixed sample immediately.
7. Add 50ul of sample to the sample well of the test card gently.
8. Observe the test strip. read the result within 3-10 min, otherwise, the result may become invalid after 15 min.

[Interpretation of Results]

Negative:

If only the quality control line C appears, and the test lines M and G are not colored, it indicates that no antibody is detected, and the result is negative.

Positive:

• IgM positive: If both the quality control line C and the test line M appear colored, it indicates that the IgM antibody is detected, and the result is positive for the IgM antibody.
• IgG positive: If both the quality control line C and the test line G appear colored, it indicates that the IgG antibody is detected, and the result is positive for the IgG antibody.
• IgM and IgG positive: If the quality control line C and the test line M and G all appear colored, it indicates that the IgM and IgG antibodies are detected, and the result is positive for both IgM and IgG antibodies.

Invalid:

If the quality control line C is not observed, the test result is invalid regardless of whether there is a colored test line, and it should be tested again.

[Limitations]

1. The antibody fast detection kit is for qualitative assessment only.
2. The test results of this product are for reference only and are not the sole basis for diagnosis and treatment. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods.
3. Due to the limitation of detection sensitivity, negative results may be caused by antibody concentrations lower than the analytical sensitivity of the product.

 

[Precautions]

1. The operation should be performed in strict accordance with the instructions. Do not use expired or damaged products.
2. Take care to prevent virus infection when collecting samples. Please wear disposable gloves and masks when sampling, and wash your hands after testing.
3. The test card is capable of showing results in 3 minutes, and the whole process takes about 8 minutes.
4. When interpreting the result, if the test line M/G shows purple-red color, it is considered a positive result. For positive results, it is recommended to use the colloidal gold retest cards attached for retesting. If the result is still positive, please contact local hospitals or disease control centers immediately.
5. If the quality control line C does not appear, please use the colloidal gold retest cards attached for retesting.
6. It takes a period of time for the antibody to be produced in the human body. It is recommended to retest 5-7 days after the first test.
7. This test card is for one-time use only. The used test cards and blood collection consumables should be properly discarded according to relevant regulations.