COVID-19 is an acutely resolved disease, but it can also be fatal with a case fatality rate of 2%. The onset of severe disease can result in death due to massive alveolar damage and progressive respiratory failure. The pathogen has since been identified as a zoonotic coronavirus, similar to SARS coronavirus and MERS coronavirus, and named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The principle of the COVID-19 IgM/IgG Antibody Test is an antibody-antibody-antigen gold conjugate immunochromatographic assay for the simultaneous detection of IgM and IgG antibodies against the COVID-19 virus in human serum, plasma or blood samples. . The COVID-19 virus recombinants are conjugated to a colloidal gold and deposited on the conjugate pad. Anti-human IgG and IgM antibodies are respectively immobilized on two test lines of the nitrocellulose membrane. When the sample is added, the antigen-gold conjugate is rehydrated and the IgM or IgG COVID-19 antibodies, if present in the sample, will react with the antigen-gold conjugate to form an antibody-antigen-gold complex.

1. For professional in vitro diagnostic use only. Do not reuse.
2. Do not use if the bag is opened or its packaging is damaged.
3. Do not use after the expiration date shown on the bag.
4. Do not mix or exchange different samples.
5. This test should be performed at a temperature of 15 to 30°C (59 to 86°F). If stored refrigerated, ensure test units are brought to operating temperature before testing.
6. Wear protective clothing such as lab coats, disposable gloves, and eye protection while handling potentially infectious materials or performing the assay.
7. Wash your hands thoroughly after finishing testing.
8. Do not eat, drink, or smoke in the area where samples or kits are handled.
9. Clean spills thoroughly with appropriate disinfectants.
10. Handle all samples as if they contained infectious agents. Adhere to established precautions against microbiological hazards throughout testing procedures.
11. Dispose of all samples and used devices in an appropriate biohazard container. Handling and disposal of hazardous materials must follow local, regional or national regulations.
12. Keep out of reach of children.