The test is intended for use as an aid in identifying individuals with specific antibodies against SARS-CoV-2 Spike/RBD ACE2 binding domains, thus providing more relevant information regarding the presence of neutralizing Abs (nAb) or other blocking antibody (bAb) in patient blood than the existing EUA approved COVID-19 antibody tests. Currently, it is unknown for how long such blocking antibodies persist following infection and if the presence of ACE2 blocking antibodies confers protective immunity. The NIDS® COVID-19 Neutralizing Antibody Test should not be used to diagnose acute SARS-CoV-2 infection.
Assessment of NIDS® COVID-19 Neutralizing Antibody Test results should be performed after both the positive and negative controls have been tested and confirmed. If the controls are not valid, the patient results cannot be interpreted.
For semi-quantitative results, the NIDS® handheld reader can be used which will provide readouts for positive-High bAb, positive-Moderate bAb, positive-Low bAb, as well as negative bAb results which can be uploaded via Bluetooth, removeable SD card, or directly to a computer or laptop.
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NIDS® COVID-19 Neutralizing Antibody Test
The NIDS® COVID-19 Neutralizing Antibody Test is a rapid, competitive Lateral Flow Immunoassay (LFI). It is for qualitative or semi-quantitative detection of total antibodies that block the interactions between SARS-CoV-2 S/RBD protein and ACE2 receptor binding. The test will use a drop of finger stick whole blood sample. Test samples can be collected by a healthcare provider (HCP) and the result will be available in about 15 minutes. Other samples, such as serum or plasma samples collected by a healthcare provider can also be used. The test result can be observed visually or with a handheld digital reader instrument.
SARS-COV-2 Spike/RBD blocking antibodies against SARS-CoV-2 Spike/RBD ACE2 binding domains can block or neutralize the binding between the SARS-COV-2 virus and the ACE2 receptor on cell membranes, therefore blocking virus infection to the human cells.