Intestinal Alkaline Phosphatase Biomarker Detection for NEC Diagnosis
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Solution Overview
Problem
Current methods for diagnosing gastrointestinal diseases, particularly necrotizing enterocolitis (NEC) in pre-term infants, are challenging due to nonspecific symptoms and rapid deterioration, leading to delayed and inaccurate diagnosis.
Innovation Solution
A method involving the use of intestinal alkaline phosphatase (iAP) as a biomarker, where a biological sample is incubated with a binding agent, and the iAP-bound agent is detected and measured for enzymatic activity, protein levels, or post-translational modifications to diagnose or predict gastrointestinal diseases.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If radiographic evidence is used to diagnose gastrointestinal disease, then diagnosis can be made in advanced stage, but diagnosis is delayed and inaccurate in early stage
Solution Approach 1:
The patent applies preliminary action by detecting iAP biomarker changes in biological samples before clinical symptoms and radiographic signs appear. The method measures iAP activity, protein levels, or post-translational modifications as early indicators of gastrointestinal disease, enabling diagnosis before the disease progresses to advanced stages requiring radiographic confirmation.
2Reliability
If traditional diagnostic methods are used, then diagnosis can be made, but symptoms are nonspecific and disease progression is rapid
Solution Approach 1:
The patent uses iAP biomarker as an intermediary substance that provides specific and reliable information about gastrointestinal disease state. By measuring iAP activity, protein levels, or post-translational modifications in biological samples, the method obtains reliable diagnostic data without directly observing nonspecific clinical symptoms or requiring complex radiographic procedures.
3Reliability
If early detection methods are implemented, then mortality and morbidity can be reduced, but detection sensitivity and specificity must be high
Solution Approach 1:
The patent applies parameter changes by measuring multiple iAP-related parameters including enzymatic activity, protein levels, and post-translational modifications. This multi-parameter approach enhances detection sensitivity and specificity, allowing reliable early diagnosis while managing the complexity of biomarker measurement through standardized assays.
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 early and accurate identification of gastrointestinal diseases, including NEC, with high sensitivity and specificity, potentially reducing mortality and morbidity by enabling timely intervention.
Implementation Method 1
incubating a biological sample from a subject with an agent that binds intestinal alkaline phosphatase (iAP), detecting in the sample iAP-bound agent
Implementation Method 2
detecting and/or measuring in the sample the amount or activity of iAP in sample, whether bound to the agent or not
Implementation Method 3
substrate can be provided for the enzyme in the sample, and the change of the substrate is monitored
Data Source
AI summary
This invention comprises compositions and methods to detect and treat gastrointestinal diseases.