Chimeric Protein Diagnostic for Visceral Leishmaniasis
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Solution Overview
Problem
Current diagnostic methods for Visceral Leishmaniasis (VL) in humans and dogs are inadequate, particularly for canine VL, due to low sensitivity and specificity, and the lack of reliable serological tests.
Innovation Solution
Development of synthetic chimeric proteins combining antigenic regions of efficient proteins for VL diagnosis, which are used in diagnostic compositions and kits for improved sensitivity and specificity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current diagnostic methods are used for Visceral Leishmaniasis in humans and dogs, then the diagnostic process can be performed with existing tests, but the sensitivity and specificity are low leading to inadequate diagnosis
Solution Approach 1:
The patent combines multiple antigenic regions from different Leishmania proteins (Lai1, Lai2, Lai3, Lai12, Lai13) into a single chimeric protein construct. This merging of multiple antigenic determinants into one molecule allows simultaneous detection of multiple immune responses, thereby increasing both sensitivity and specificity of the diagnostic test while maintaining reliability
Solution Approach 2:
The chimeric protein is constructed as a composite molecular structure containing fused antigenic regions from multiple native Leishmania proteins. This composite approach creates a novel diagnostic antigen that leverages the immunogenic properties of each component protein, achieving superior diagnostic performance compared to individual protein-based tests
2Measurement precision
If existing diagnostic tests are used, then the testing procedure is simpler, but the performance is inadequate particularly for canine VL and asymptomatic cases
Solution Approach 1:
Multiple antigenic regions that would traditionally require separate tests are merged into a single chimeric protein. This allows a single diagnostic test to replace multiple individual protein tests, improving diagnostic performance while the complexity is managed through rational protein design and standardized production protocols
3Measurement precision
If chimeric proteins are developed combining multiple antigenic regions, then sensitivity and specificity are improved, but the manufacturing process becomes more complex
Solution Approach 1:
The chimeric protein is designed by segmenting and fusing specific antigenic regions (epitopes) from multiple native proteins. This segmentation approach allows modular construction of the chimeric protein, enabling systematic optimization of each antigenic component while maintaining overall manufacturability through standardized cloning and expression protocols
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 demonstrate high sensitivity and specificity in diagnosing VL in humans and dogs, with improved performance compared to existing tests, particularly in asymptomatic cases.
Implementation Method 1
contact one or more chimeric proteins with a human or dog serum sample, Detect the chimeric protein/antibody complex formed in the previous step using an immunological detection technique
Data Source
AI summary
The present invention relates to chimeric proteins, their uses and production method comprising native protein fractions from Leishmania infantum for the Visceral Leishmaniasis diagnosis. The invention also relates to nucleic acid, expression cassette, expression vector, host cell, visceral leishmaniasis diagnostic kit, visceral leishmaniasis diagnostic kit, visceral leishmaniasis diagnostic method, and vaccine composition.