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US 2023/0375568 A1Published application
Neutralizing antibody immunoassays
AssigneeInBios International, Inc.
InventorsGregory Ireton, Syamal Raychaudhuri, James Needham, Dindo Reyes
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Abstract
The present disclosure provides compositions and methods for detecting the presence of neutralizing antibodies in a sample. Unlike conventional assays, the methods provided herein do not require the use of live virus or virus pseudoparticles to identify neutralizing antibodies.
Claims16
1-30. (canceled)
A lateral flow assay comprising:
- a nitrocellulose membrane;
- a sample pad resting on the nitrocellulose membrane at a sample end;
- a conjugate pad resting on the nitrocellulose membrane in a direction of sample flow after the sample pad and comprising a labeled SARs-CoV-2 spike protein and a labeled control antibody that specifically binds a control target protein;
- a bridge pad resting on the nitrocellulose membrane in a direction of sample flow after the conjugate pad;
- a test line and a control line on the nitrocellulose membrane both in a direction of sample flow after the bridge pad, wherein the test line comprises a human ACE2 protein eciodomain bound to the nitrocellulose membrane and the control line comprises the control target protein bound to the nitrocellulose membrane;
- and an absorbent pad in a direction of sample flow after the conjugate pad.
3 more elements
A method of detecting antibodies that are neutralizing for SARS-CoV-2 spike protein binding to human ACE2, the method comprising:
- (a) placing a sample comprising antibodies on the sample pad of an assay according to claim 1;
- (b) allowing the sample to remain on the assay for a period of time sufficient for the sample to flow over the test line and the control line and for SARS-CoV-2 spike protein in the sample to bind to human ACE2 in the test line;
- and (c) viewing the test line and the control line to determine if the control line is visible, indicating a valid assay, and if the test line is visible, indicating an absence or limited amount of neutralizing antibodies in the sample.
Dependencies are inferred from the claim text.