CE 8 Minute Diagnostic Kit Colloidal Gold Antibody IFP-3000

Result in 8 Minute SARS-CoV-2 Neutralizing Antibody Rapid Test Kit

INTENDED USE:

For in vitro qualitative detection of human IgG antibodies against SARS-CoV-2 and neutralizing antibodies that block the interaction between the receptor-binding domain of the viral spike glycoprotein (RBD) with the ACE2 cell surface receptor in serum, plasma, and whole blood. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing. Home-testing by laypersons is subject to local legislation. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease 2019 (COVID-19), which is contagious in humans. SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M), and nucleocapsid (N). The spike protein (S) contains a receptor-binding domain (RBD), which is responsible for recognizing the cell surface receptor, angiotensin-converting enzyme-2 (ACE2). It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2 receptor leading to endocytosis into the host cells of the deep lung and viral replication. Infection with the SARS-CoV-2 initiates an immune response, which includes the production of antibodies in the blood. The secreted antibodies provide protection against future infections from viruses because they remain in the circulatory system for months to years after infection and will bind quickly and strongly to the pathogen to block cellular infiltration and replication. These antibodies are named neutralizing antibodies. For in vitro diagnostic use only. For professional use only

WARNING AND PRECAUTIONS:

1. Test cassettes are single use only. Do not reuse test cassettes.

2. For IN VITRO Diagnostic use only.

3. This test is only intended for detecting the presence of IgG antibodies and neutralizing antibodies against SARS-CoV2, not for any other viruses or pathogens.

4. All human blood products should be handled as potentially infectious material.

5. Never pipette by mouth or allow reagents or patient sample to come into contact with skin.

6. Optimal results will be obtained by strict adherence to this protocol. Reagents must be added carefully to maintain precision and accuracy.

7. Performing the assay outside the prescribed time and temperature ranges may produce invalid results. Assays not falling within the established time and temperature ranges must be repeated.

8. The components in this kit have been quality control tested as a master lot unit. Do not mix components from different lot numbers. Do not mix with components from other manufacturers.

9. Care should be exercised to protect the reagents in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results. Do not heat-inactivate samples.

10. Keep storage boxes dry.

11. Do not use test cassettes if foil pouch is punctured or damaged.

12. Testing materials should be disposed of in accordance with local, state and/or federal regulations.

13. Do not use after the expiration date.

14. Please read the instructions carefully before operation and follow the instructions.

15. Please use fresh samples as much as possible, and avoid using samples contaminated with bacteria, hemolysis, jaundice, or excessive blood lipid.

16. Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.

17. Do not perform the test in a room with strong airflow, i.e. an electric fan or strong air-conditioning.

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