Nanoparticle Urine Antigen Capture for TB Diagnosis
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Solution Overview
Problem
Current diagnostic methods for infectious diseases like tuberculosis, Chagas disease, and Lyme disease face challenges due to low abundance of disease-derived proteins in urine, inadequate sensitivity, and the need for invasive procedures, especially in resource-limited settings and for populations such as infants, immunocompromised individuals, and the elderly.
Innovation Solution
The development of nanoparticles with a core and shell structure, functionalized with molecular baits to capture and concentrate biomolecules, nucleic acids, and viruses from urine, blood, or saliva, enabling sensitive and specific detection using mass spectrometry and visual lateral flow assays, without the need for refrigeration or trained personnel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional diagnostic methods (smear microscopy, culture, PCR) are used for TB detection, then diagnostic accuracy can be achieved, but invasive procedures and long waiting times are required
Solution Approach 1:
The invention extracts and detects TB-specific antigens (ESAT-6 and CFP-10) directly from urine samples, eliminating the need for invasive sputum collection and complex culture procedures. The urinary antigens are isolated and detected using specific antibodies in an ELISA format, providing accurate diagnosis without invasive procedures.
Solution Approach 2:
The invention uses urinary antigens as intermediary markers that reflect TB infection status without requiring direct examination of the pathogen or its genetic material. The antigens serve as mediators that can be detected in easily collected urine samples, bridging the gap between non-invasive sampling and accurate diagnosis.
2Reliability
If conventional TB urine testing methods are used, then testing can be performed, but sensitivity is inadequate for pulmonary TB detection
Solution Approach 1:
The invention develops a multi-antigen ELISA system that detects multiple TB-specific antigens (ESAT-6 and CFP-10) simultaneously, along with other urinary markers. This multi-functional approach increases sensitivity for pulmonary TB detection while maintaining the ability to differentiate true positives from false positives through pattern recognition.
Solution Approach 2:
The diagnostic system uses a composite approach combining multiple antigens and antibodies in an ELISA format. The synergistic detection of multiple urinary antigens creates a more sensitive and specific diagnostic test than single-antigen methods, achieving high sensitivity for pulmonary TB detection.
3Ease of operation
If TB antigens are detected in urine, then non-invasive diagnosis is achieved, but antigens exist in very low concentration and are masked by high abundant urinary proteins
Solution Approach 1:
The invention employs highly specific antibodies that selectively bind to TB antigens in the complex urinary matrix. The antibodies are designed with high affinity and specificity for the target antigens, enabling detection despite the low concentration and presence of high-abundant urinary proteins. The local specificity of the antibody-antigen interaction overcomes the masking effect.
Solution Approach 2:
The ELISA methodology uses parameter optimization including antibody concentration, incubation time, and wash conditions to enhance detection sensitivity. The assay conditions are tuned to maximize the signal from low-abundance antigens while minimizing background interference from urinary proteins, achieving detectable signals despite low antigen concentrations.
4Adaptability or versatility
If field-based diagnostic testing is implemented, then accessibility to remote areas is improved, but current tests require refrigeration and trained personnel
Solution Approach 1:
The ELISA-based urinary antigen test is designed to be self-performing with minimal technical requirements. The assay includes pre-coated plates, ready-to-use antibodies, and standardized protocols that can be executed by personnel with basic training. The test does not require refrigeration during the assay process, enabling field deployment in resource-limited settings.
Solution Approach 2:
The invention uses disposable ELISA plates and reagents that eliminate the need for expensive, complex equipment and extensive training. The single-use format ensures consistency and reduces the risk of contamination, while the simplicity of the protocol allows field deployment without sophisticated infrastructure or highly trained personnel.
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 approach allows for the first-time detection of low-abundance TB and Chagas disease antigens with high sensitivity and specificity, reducing diagnostic delays and costs, and enabling point-of-care testing in resource-constrained environments.
Implementation Method 1
nanoparticles with a core and shell structure, functionalized with molecular baits to capture and concentrate biomolecules
Implementation Method 2
enabling sensitive and specific detection using mass spectrometry
Implementation Method 3
visual lateral flow assays
Data Source
AI summary
The invention relates to a relates to a highly sensitive, non-invasive diagnostic method for detection infectious diseases. In one embodiment, the invention relates to novel rapid, self-working, visual field test for a panel of disease specific derived biomarkers. In one embodiment, the invention comprises a collecting device comprising a collapsible non hygroscopic net tethered with immobilized nanoparticles to capture and concentrate a target analyte present in a fluid; wherein the nanoparticle comprises a core and a shell, wherein the core comprises a molecular bait. The invention also relates to identification of biomarkers for identification of various pathogenic diseases.