Polypeptide Signatures for Rapid Infection Diagnosis
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Solution Overview
Problem
Current diagnostic technologies for infectious diseases, such as culture and PCR, face challenges in accurately differentiating between bacterial and viral infections, distinguishing between pathogenic and non-pathogenic bacteria, and diagnosing inaccessible infections, leading to inappropriate antibiotic prescriptions and resistance issues.
Innovation Solution
The development of methods to identify specific polypeptide signatures, like TRAIL and CRP, in non-human subjects to differentiate between bacterial, viral, and mixed infections, allowing for rapid and accurate diagnosis without the need for direct sampling, and guiding appropriate treatment regimens.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current diagnostic technologies (culture, PCR, immunoassays) are used to identify infections, then diagnostic accuracy is limited, but the time required for diagnosis increases to hours or days
Solution Approach 1:
The patent segments the diagnostic process into two distinct phases: (1) rapid screening using polypeptide signature analysis to identify potential infections within minutes, and (2) confirmatory testing using traditional methods like culture or PCR. This segmentation allows the system to deliver quick preliminary results without sacrificing diagnostic accuracy, as the polypeptide signatures serve as highly specific indicators that narrow down potential pathogens before confirmatory tests are performed.
Solution Approach 2:
The invention performs preliminary diagnostic action by analyzing polypeptide signatures in blood samples to rapidly identify the presence and type of infection before traditional diagnostic methods are completed. The polypeptide signature analysis serves as a preliminary screening tool that can distinguish between bacterial, viral, and fungal infections within minutes, allowing clinicians to initiate appropriate treatment protocols while awaiting confirmatory results from slower methods.
2Reliability
If antibiotics are prescribed without accurate diagnosis, then treatment coverage is broadened, but antibiotic resistance increases and unnecessary side effects occur
Solution Approach 1:
The patent implements a feedback mechanism where polypeptide signature analysis results directly inform antibiotic prescription decisions. The system provides real-time feedback to clinicians about the likely infection type (bacterial, viral, or fungal) based on the detected polypeptide profile, enabling evidence-based prescribing decisions. This feedback loop prevents unnecessary antibiotic prescriptions for viral infections while ensuring appropriate antibiotic selection for confirmed bacterial infections, thereby reducing resistance development and adverse events.
Solution Approach 2:
The invention changes the diagnostic parameter from detecting pathogen presence directly (which requires invasive sampling and time-consuming culture) to detecting host immune response markers (polypeptides) that indicate infection type. This parameter change enables rapid differentiation between bacterial and viral infections through blood-based polypeptide analysis, providing the information needed to make appropriate antibiotic prescribing decisions without exposing patients to unnecessary antibiotics.
3Measurement precision
If direct sampling of infection site is performed, then pathogen detection accuracy improves, but the procedure becomes invasive and inapplicable to inaccessible tissues
Solution Approach 1:
The patent uses polypeptides in the blood as intermediary markers that reflect the presence and type of infection at distant sites without requiring direct sampling of the infection focus. These polypeptide signatures serve as mediators between the remote infection site and the diagnostic test, allowing clinicians to infer the nature of infections in inaccessible tissues (such as pneumonia, sinusitis, or otitis media) through simple blood draws. The polypeptides carry information about the infection type from the affected tissue to the circulating bloodstream, enabling non-invasive diagnosis.
Data Source
AI summary
Antibiotics (Abx) are the world's most misused drugs. Antibiotics misuse occurs when the drug is administered in case of a non-bacterial infection (such as a viral infection) for which it is ineffective. Overall, it is estimated that 40-70% of the worldwide Abx courses are mis-prescribed. The financial and health consequences of Abx over-prescription include the direct cost of the drugs, as well as the indirect costs of their side effects, which are estimated at >$15 billion annually. Furthermore, over-prescription directly causes the emergence of Abx-resistant strains of bacteria, which are recognized as one of the major threats to public health today. This generates an immediate need for reliable diagnostics to assist physicians in correct Abx prescription, especially at the point-of-care (POC) where most Abx are prescribed. Accordingly, some aspects of the present invention provide methods using biomarkers for rapidly detecting the source of infection and administrating the appropriate treatment.