NIDS® COVID-19 ACE2 Blocking Antibody Test
The NIDS® COVID-19 ACE2 Blocking 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.
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 ACE2 Blocking Antibody Test should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests.
The NIDS® COVID-19 ACE2 Blocking Antibody Test is only for use under the Food and Drug Administration’s Emergency Use Authorization, currently pending review.
Assessment of NIDS® ACE2 Blocking 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.