REF:

F2101 (Cassette)

INTENDED USE:

Detector(TM) system SARS-CoV-2 Neutralizing Antibodies FIA Test is an immunofluorescence-based lateral flow assay intended for semi-qualitative detection of SARS-CoV-2 neutralizing antibodies from human in sera specimens (serum/plasma/whole blood) and designed for evaluate individual’s adaptive immune responsivity 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.

Until now, it is unknown for how long antibodies persist following infection and if the presence of neutralizing antibodies confers protective immunity. 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.

Atlas Link Detector(TM) System for Rapid Detection of SARS-CoV-2 neutralizing antibody is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.

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. Detector(TM) system SARS-CoV-2 Neutralizing Antibodies FIA Test kit is specific to SARS-CoV-2 neutralizing antibodies.

Atlas Link Detector(TM) System for rapid detection of SARS-CoV-2 neutralizing antibody is a rapid immunofluorescence assay for the direct detection of the presence or absence SARS-CoV-2 neutralizing antibody in blood specimens (Serum/Plasma Whole blood) taken from patients with previous infections or who are vaccinated. The test is intended for interpretation in both laboratory and near patient testing environments only withAtlas Link Detector(TM) analyzer instrument.

Procedures to evaluate test devices depend on the Atlas Link Detector analyzer workflow configuration chosen. InDirect mode, the instrument evaluates assay devices after manual timing of their development. InDelay mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Additionally, connection of an Atlas Link Detector analyzer to a blue-tooth wireless printer or PC with USB cable is possible if desired. Additional calibration and analysis software is available in PC is also provided.