Analysis of anti-erythrocyte antibody in the presence of antibody directed against a surface-bound erythrocyte antigen

Inventors

SCHNEEWEISS, Clemens • GRÜGER, Daniela

Assignees

Imusyn & Co KG GmbH

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Publication Number

US-11131678-B2

Patent

Publication Date

2021-09-28

Expiration Date


Abstract

An analytical process for detecting antibody in human blood serum, which antibody is directed against blood group antigen, wherein the serum contains an additional antibody directed against a surface antigen, by contacting the serum to be analysed with blood cell membranes, which naturally bear surface blood group antigens, followed by detection of agglutination which indicated the presence of antibody directed against at least one surface antigen of the blood cell membranes. The agglutination reaction caused by the additional antibody is prevented, allowing the detection of anti-blood group antibody.

Core Innovation

The invention is an analytical process for detecting an antibody specific for a blood group antigen in blood serum. The serum is contacted with blood cell membranes bearing surface antigens, and before this contacting, at least one binding peptide specifically binding to a first surface antigen of the blood cell membranes is added to the blood cell membranes, the binding peptide having no human Fc region. The blood cell membranes are red blood cells or membrane fragments of red blood cells.

The problem addressed is interference in analytical serology caused by an additional antibody that binds a surface antigen on erythrocytes. Prior masking of the first surface antigen prevents this interference while allowing detection of antibodies against blood group antigens. Agglutination from anti-CD38/daratumumab is abolished by pre-incubation with the Fc-less binding peptide, while agglutination by true blood-group antibodies remains unaffected.

Claims Coverage

The independent claim covers 1 inventive feature centered on an analytical process that uses prior masking of a first surface antigen on red blood cell membranes with a binding peptide lacking a human Fc region before detection of an antibody specific for a blood group antigen.

Prior masking of a first surface antigen

Before contacting the serum with blood cell membranes, at least one binding peptide specifically binding to a first surface antigen of the blood cell membranes is added to the blood cell membranes, and the binding peptide has no human Fc region.

Red blood cell membranes as the assay substrate

The blood cell membranes are red blood cells or membrane fragments of red blood cells.

Detection of antibody specific for a blood group antigen

The process detects an antibody specific for a blood group antigen in blood serum by contacting the serum with blood cell membranes bearing surface antigens.

The claim is directed to an analytical serology process in which Fc-less binding peptide masking of a first surface antigen is combined with red blood cell membrane-based detection of blood group antibodies.

Stated Advantages

Prevents interference from an additional antibody that binds a surface antigen on erythrocytes.

Allows agglutination caused by anti-CD38/daratumumab to be abolished by pre-incubation with the Fc-less binding peptide.

Allows true blood-group antibody agglutination to remain unaffected.

Converts non-conclusive or positive results to conclusive negative results in patient serum containing anti-CD38.

Documented Applications

Analytical serology for detection of antibodies against blood group antigens in blood serum.

Detection in gel card assay.

Use in Coombs test context.

Detection involving patient serum containing anti-CD38.

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