REF:

C2104 (Cassette)

INTENDED USE:

SARS-CoV-2 Neutralizing Antibody Test is an immunochromatographic membrane assay that uses the immuno-capture method to direct detection of total neutralizing antibodies that block receptor-binding domain (RBD) to novel coronavirus (SARS-CoV-2) from human serum/plasma/whole blood specimens.

SARS-CoV-2 Neutralizing Antibody Test is intended for identifying individuals with adaptive immune response to SARS-CoV-2, indicating recent or prior infection or vaccination. Performance of the test should not be used to diagnose acute SARS-CoV-2 infection. The test kit is for professional use only.

At this time, it is unknown for how long antibodies persist following infection and if the presence of neutralizing antibodies confers protective immunity. The sensitivity of the SARS-CoV-2 Neutralizing Antibody Test early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

For in vitro diagnostic use only.

SUMMARY:

Novel coronavirus pneumonia (Coronavirus disease 19, COVID-19) is an infectious disease caused by SARS-CoV-2 infection. On February 11, 2020 the International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2. 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. Immune cells secrete antibodies when immune response initiated and subpopulation of the antibodies that can block cellular infiltration and viral replication are called neutralizing antibodies. It is unknown how long it takes for neutralizing antibodies to be produced, and if they are always produced after SARS-CoV-2 infection. SARS-CoV-2 Neutralizing Antibody Test is specific to SARS-CoV-2 neutralizing antibodies.