Blood Screening Anti-CD38 Antibody Interference

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Solution Overview

Problem

Current methods for crossmatching patient and donor blood are interfered with by anti-CD38 antibodies, leading to false indications of incompatible matches and increased risk of hemolytic transfusion reactions, especially in cancer patients treated with daratumumab or isatuximab.

Innovation Solution

A method for screening blood samples from patients treated with anti-CD38 antibodies, involving the use of a specific anti-CD38 antibody or antigen binding fragment that does not cause agglutination with donor red blood cells, even in the presence of patient-derived antibodies, thereby allowing accurate crossmatching without the need for additional processing steps.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional crossmatching methods are used on patients treated with anti-CD38 antibodies, then the standard blood screening process can be performed, but false indications of incompatible matches occur leading to increased risk of hemolytic transfusion reactions

Engineering Contradiction:
Improveaccuracy of crossmatchingVSAvoidfalse positive interference from anti-CD38 antibodies
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent removes the interfering anti-CD38 antibodies from the patient serum through adsorption onto solid support beads coated with human IgG, isolating the clinically significant antibodies for accurate detection in crossmatching procedures

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces solid support beads coated with human IgG as an intermediary substance that selectively binds and removes anti-CD38 antibodies from patient serum, allowing the underlying clinically significant antibodies to be detected without interference

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If additional processing steps are implemented to remove anti-CD38 antibody interference, then accurate crossmatching can be achieved, but the complexity and time required for blood screening increases

Engineering Contradiction:
Improvedetection accuracy of clinically significant antibodiesVSAvoidadditional processing steps required
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs disposable solid support beads that can be easily discarded after single use, eliminating the need for complex cleanup procedures and reducing the overall complexity of the blood screening process

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent divides the blood screening process into distinct sequential steps: first removing anti-CD38 antibodies using solid support beads, then performing standard crossmatching procedures, allowing each step to be optimized independently

Inventive Principle:
Principle #1Segmentation

3Productivity

If standard crossmatching is performed without removing anti-CD38 antibodies, then the process is quick and simple, but compatible crossmatches appear incompatible causing delays in identifying suitable donor red blood cells

Engineering Contradiction:
Improvespeed of blood screeningVSAvoiddelay in identifying compatible blood products
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The patent performs preliminary removal of anti-CD38 antibodies from patient serum before conducting crossmatching procedures, preventing false positive results and avoiding delays in identifying compatible blood products

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This method enables accurate detection of clinically significant patient antibodies in the presence of anti-CD38 antibodies, reducing the risk of hemolytic transfusion reactions and minimizing delays in identifying compatible blood products.

Implementation Method 1

Anti-CD38 antibodies such as daratumumab and isatuximab are known to bind to CD38 expressed on the surface of RBCs, causing interference on a range of haematological tests performed by blood banks in order to screen and match a patient's blood prior to receiving a red blood cell transfusion

Methodology Applied
Scientific EffectAgglutination:

Data Source

PatentUS20250189544A1Methods of blood screening
Publication Date: 2025.06.12 CASI PHARM INC
  • US20250189544A1 patent drawing
  • US20250189544A1 patent drawing
  • US20250189544A1 patent drawing

AI summary

The present invention relates to methods of identifying suitable donor blood for cancer patients receiving anti-CD38 antibodies as treatment. In particular, the present invention addresses problems associated with crossmatching patient and donor blood when the patient blood comprises anti-CD38 antibodies that interfere with crossmatching methods of the art.