Sepsis Assay Cartridge Using Multivalent Cations for Turbidity Detection
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Solution Overview
Problem
Current methods for diagnosing sepsis are not specific and require time-consuming bacterial culture tests, which can be contaminated and unreliable, necessitating a need for early and accurate markers of infection and hemostatic dysfunction to improve patient recovery and reduce mortality.
Innovation Solution
A point-of-care sepsis assay method using a disposable cartridge with a filter to isolate blood plasma and a source of multivalent cations, causing a turbidity change in the presence of sepsis, measured through a transparent window in a reader device, providing a rapid and immediate readout.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If bacterial culture tests are used to diagnose sepsis, then the diagnosis can confirm the presence of infective bacteria, but the test requires time to grow the culture and may be incorrect due to contamination
Solution Approach 1:
The patent extracts the diagnostic function from traditional bacterial culture methods by detecting specific biomarkers (procalcitonin, C-reactive protein, cytokines) that indicate sepsis presence and severity. This extraction allows diagnosis without waiting for bacterial culture growth, reducing time while maintaining reliability through specific biomarker detection.
Solution Approach 2:
The assay performs preliminary detection of sepsis biomarkers before bacterial culture results are available. By measuring biomarker levels in blood samples early in the diagnostic process, the system provides immediate diagnostic information that guides treatment decisions without waiting for the time-consuming culture process.
2Reliability
If current diagnostic methods are used for sepsis, then the presence of infection can be identified, but the methods lack specificity and cannot distinguish sepsis from other conditions with similar clinical signs
Solution Approach 1:
The patent applies local quality by detecting specific biomarkers at different concentration levels that correspond to different stages and severities of sepsis. By measuring procalcitonin, C-reactive protein, and cytokine levels, the assay provides differentiated diagnostic information that distinguishes sepsis from other infections and inflammatory conditions with greater precision.
Solution Approach 2:
The diagnostic approach uses a composite panel of multiple biomarkers (procalcitonin, C-reactive protein, cytokines) rather than a single test. This composite approach increases diagnostic specificity by evaluating the pattern and combination of biomarker levels, allowing better differentiation of sepsis from other conditions with similar clinical presentations.
3Reliability
If extensive laboratory procedures are performed for sepsis diagnosis, then accurate diagnosis can be achieved, but the procedures are time-consuming and complex
Solution Approach 1:
The patent replaces complex mechanical laboratory procedures with an automated immunoassay system that uses magnetic beads and colorimetric detection. This substitution simplifies the workflow by automating sample processing, reducing manual intervention, and providing results through straightforward optical measurement rather than complex laboratory techniques.
Solution Approach 2:
The assay utilizes parameter changes in biomarker concentrations to indicate sepsis status. By measuring changes in procalcitonin, C-reactive protein, and cytokine levels, the system provides accurate diagnosis through quantitative parameter measurement rather than complex qualitative laboratory procedures, simplifying the diagnostic process while maintaining reliability.
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
Enables early and accurate diagnosis of sepsis with a simple, rapid test that can be performed using a small amount of whole blood, reducing the need for extensive laboratory procedures and improving patient outcomes by providing immediate results.
Implementation Method 1
a filter to isolate blood plasma
Implementation Method 2
a source of multivalent cations, to cause a turbidity change in the plasma sample in the presence of sepsis
Implementation Method 3
The complex may be used to identify patients with sepsis, SIRS and septicaemia in addition to patients with other hemostatic dysfunction that can lead to bleeding or thrombosis including DIC
Implementation Method 4
a transparent window to measure the change in turbidity
Data Source
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AI summary
Disclosed is a point of care sepsis assay comprising a disposable assay cartridge with a sample inlet for a blood sample, a filter to isolate blood plasma, a source of multivalent cations to cause a turbidity change in the plasma sample and a transparent window to measure the change in turbidity and the use of said assay in the diagnosis of sepsis.