Immunoassay Blocking Antibody Variants for Interference Reduction
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Solution Overview
Problem
Conventional immunoassays face challenges in accurately analyzing samples due to insufficient blocking of interfering antibodies like heterophilic antibodies and rheumatoid factors, leading to false-positive or false-negative results despite the use of conventional blocking reagents.
Innovation Solution
A kit and method utilizing a blocking antibody with an amino acid sequence identical to the analytical antibody, except for one to three modified residues, significantly reduces antigen-binding capacity to effectively block interfering antibodies, enhancing assay reliability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional blocking reagents (mixtures of irrelevant antibodies) are used to block interfering antibodies, then the blocking effect is partially achieved, but false-positive or false-negative results still occur in certain samples
Solution Approach 1:
The patent modifies the amino acid sequence of the analytical antibody by changing one to three residues to create a blocking antibody variant. This parameter change in the antibody structure allows it to block interfering antibodies while maintaining sufficient antigen-binding capacity, resolving the contradiction between blocking effectiveness and detection accuracy
Solution Approach 2:
The blocking antibody is created as a modified copy of the analytical antibody, retaining most of its structure and binding properties. This copying approach with minimal modifications enables the blocking antibody to effectively compete with interfering antibodies while the analytical antibody continues to provide accurate detection
2Reliability
If the amino acid sequence of the blocking antibody is made identical to the analytical antibody except for one to three modified residues, then antigen-binding capacity is greatly reduced, but blocking of interfering antibodies is significantly improved
Solution Approach 1:
The patent applies local quality change by modifying only one to three specific amino acid residues in the antibody sequence rather than changing the entire structure. This localized modification selectively reduces antigen-binding capacity at the binding site while preserving the overall antibody structure and its ability to block interfering antibodies
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
The modified antibody variant efficiently blocks interfering antibodies, ensuring accurate and interference-free detection of analytes by minimizing the analyte-specific detection reaction by up to 15%, thereby improving the reliability of immunoassays.
Implementation Method 1
an antibody variant which has a second amino acid sequence and the antigen-binding capacity of which is greatly reduced compared to the first antibody such that its additional use in the defined test system for detection of the analyte reduces the analyte-specific detection reaction by a maximum of 15%
Data Source
AI summary
A kit and method are described herein for detecting an analyte in a body fluid sample. The kit and method use a test-specific blocking antibody for reduction of interferences, for example as caused by heterophilic antibodies or rheumatoid factors.