VAPERON Neutralizing Antibody Rapid Detection Kit

VAPERON Neutralizing Antibody Rapid Detection Kit | COVNA-503 | NOVA Test

INTENDED USE:

NOVA Test®SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold Immunochromatography) 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/Na2-EDTA plasma/whole blood specimens. NOVA Test®SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit is intended for identifying individuals with adaptive immune response to SARSCoV-2, indicating recent or prior infection or vaccination. Performance of the test is should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified to perform moderate or high complexity tests.

SUMMARY AND EXPLANATION:

Novel coronavirus pneumonia (Coronavirus disease 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. NOVA Test®SARS-CoV-2 Neutralizing Antibody Rapid Detection Kit is specific to SARS-CoV-2 neutralizing antibodies.

Specimen:

WB/S/P

Format:

Cassette