REF:

C2110 (Cassette)

INTENDED USE:

SARS-CoV-2 Neutralizing Antibody Semiquantitative 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 Semiquantitative Test is intended for evaluating 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. Negative results do not preclude acute SARS-CoV-2 infection or recent vaccination. 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 Semiquantitative Test is specific to SARS-CoV-2 neutralizing antibodies.