The COVID-19 ImmunoRank™ Neutralization MICRO-ELISA is a test for semi-quantitative detection of SARS-CoV-2 neutralizing antibodies in plasma or serum. This assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 indicating recent or prior infection and detection of circulating SARS-CoV-2 neutralizing antibodies of all Ig classes. At this time, it is unknown for how long antibodies persist following infection and if the presence of neutralizing antibodies confers protective immunity. The COVID-19 ImmunoRank™ Neutralization MICRO-ELISA test should not be used to diagnose acute SARS-CoV-2 infection.
The test is a solid phase enzyme-linked immunosorbent assay (ELISA) using a chromogenic enzyme substrate as an indicator. The SARS CoV-2 recombinant viral entry receptor protein, angiotensin-converting enzyme 2 (ACE2), is immobilized to polystyrene wells of a microplate (solid phase). In the wells of a separate incubation plate, a positive control, negative control, calibrator control and test specimens are diluted and added to the wells along with the diluted soluble recombinant SARS CoV-2 receptor binding domain (RBD) recombinant protein conjugated to horseradish peroxidase.