Chimeric Recombinant Proteins for Lyme Disease Diagnosis
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Solution Overview
Problem
Current diagnostic methods for Lyme disease fail to detect antibodies with high specificity and sensitivity, as no individual protein or combination of proteins has proven effective in identifying Lyme disease spirochete-directed antibodies.
Innovation Solution
Development of chimeric recombinant proteins comprising multiple Borreliella proteins or variants, such as DbpB, DbpA, BBK19, BBK53, VlsE, and BB0238, which are designed to detect anti-Borreliella antibodies with high specificity and sensitivity in diagnostic assays.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If individual proteins or simple combinations of proteins are used for Lyme disease diagnosis, then the diagnostic assay is simpler to produce, but the specificity and sensitivity of antibody detection is insufficient
Solution Approach 1:
The patent combines multiple Borreliella protein sequences into a single chimeric recombinant protein that contains immunogenic regions from at least two different Borreliella proteins. This merging approach allows the diagnostic assay to detect a broader range of anti-Borreliella antibodies with high specificity and sensitivity while maintaining a single protein structure rather than requiring multiple separate proteins.
Solution Approach 2:
The chimeric recombinant protein functions as a composite molecular material, integrating antigenic determinants from multiple Borreliella protein sources (such as OspC, DbpA, DbpB, VlsE) into one unified structure. This composite approach enables the protein to elicit and detect multiple antibody responses simultaneously, resolving the contradiction between detection precision and structural complexity.
2Reliability
If multiple individual proteins are produced separately for diagnostic assays, then the detection coverage is comprehensive, but the production cost and complexity increase significantly
Solution Approach 1:
The patent merges multiple protein production processes into a single chimeric protein production process. By consolidating the immunogenic regions of multiple Borreliella proteins into one recombinant protein, the manufacturing process requires only single protein expression, purification, and validation steps, dramatically reducing production costs and complexity while maintaining comprehensive detection coverage.
Solution Approach 2:
The chimeric recombinant protein serves multiple diagnostic functions simultaneously - it can detect antibodies against different Borreliella strains and protein types (outer surface proteins, decorin-binding proteins, variable surface proteins) within a single assay, replacing the need for multiple separate protein products and enabling comprehensive detection with a single manufactured product.
3Measurement precision
If traditional diagnostic assays using multiple proteins are used, then the antibody detection is thorough, but the interpretation of test results becomes complicated
Solution Approach 1:
The patent combines multiple antigenic targets into a single chimeric protein, which simplifies the diagnostic assay to a single detection step. The test result interpretation becomes straightforward - a positive signal indicates the presence of anti-Borreliella antibodies against the chimeric protein's embedded antigens - eliminating the complexity of interpreting results from multiple separate protein assays while maintaining thorough antibody detection.
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 chimeric proteins exhibit high specificity and sensitivity in detecting Lyme disease, reducing false positives and allowing for early detection of infection, and are more cost-effective to produce than multiple individual proteins.
Implementation Method 1
contacting a biological sample with the at least one recombinant chimeric polypeptide, and detecting antibody-antigen complexes formed by antibodies in the biological sample and the at least one recombinant chimeric polypeptide
Data Source
AI summary
Chimeric recombinant proteins for the detection of infection by Borreliella and/or diagnosis of Lyme disease are provided. Methods and devices for conducting immunoassays with the chimeric recombinant proteins are also provided.