Immunoassay Kit for Pre-eclampsia Detection via Factor Ba
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Solution Overview
Problem
Current methods for diagnosing pre-eclampsia in pregnant women are inadequate for early detection, leading to unnecessary hospitalizations and lack of reliable indicators before 20 weeks of gestation, as symptoms often resemble normal pregnancy complications.
Innovation Solution
A method and kit for quantitating Factor B cleavage product Ba in urine, plasma, or serum using specific antibodies to detect the presence or absence of Ba, providing a reliable means to rule out pre-eclampsia and spontaneous pre-term birth by assessing the binding of a highly-specific antibody to a neo-epitope on the Ba fragment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current diagnostic methods are used for pre-eclampsia, then hospitalization resources are consumed, but detection reliability is insufficient and unnecessary hospitalizations occur
Solution Approach 1:
The patent applies preliminary action by performing early detection of pre-eclampsia through measurement of complement activation markers (C3a, C5a, sFlt-1, PlGF) before 20 weeks of gestation. This allows identification of at-risk pregnancies early, enabling preventive monitoring and avoiding unnecessary hospitalizations later when symptoms manifest.
2Loss of time
If early detection methods are implemented, then pre-eclampsia risk can be identified sooner, but diagnostic complexity increases
Solution Approach 1:
The patent applies universality by using a multi-marker panel approach where several biomarkers (C3a, C5a, sFlt-1, PlGF) are measured simultaneously to detect pre-eclampsia risk. This multi-functional diagnostic strategy improves early detection accuracy before 20 weeks while the markers can be measured using standardized laboratory techniques, managing complexity through established methods.
Solution Approach 2:
The patent uses complement activation markers as intermediary substances that indicate pre-eclampsia risk indirectly. These markers (C3a, C5a) serve as mediators between the underlying pathological processes and the diagnostic measurement, allowing early detection through measurable surrogate indicators rather than direct observation of disease manifestations.
3Reliability
If symptoms are monitored for pre-eclampsia diagnosis, then clinical manifestations are detected, but detection occurs too late for preventive action
Solution Approach 1:
The patent implements preliminary action by measuring complement activation markers and angiogenic factors before clinical symptoms of pre-eclampsia appear. This allows detection of the pathological process in its early stages, enabling preventive monitoring and intervention before hypertension and proteinuria develop.
Solution Approach 2:
The patent applies feedback by using the measured levels of complement markers (C3a, C5a) and angiogenic factors (sFlt-1, PlGF) to provide information about pre-eclampsia risk. This feedback allows clinicians to adjust monitoring intensity and take preventive actions based on the biomarker levels detected in early pregnancy.
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 convenient, early, and reliable detection of pre-eclampsia, reducing unnecessary hospitalizations by providing a sensitive and specific indicator of pre-eclampsia risk, even before symptoms become severe.
Implementation Method 1
assessing the binding of a highly-specific antibody to a neo-epitope on the Ba fragment
Data Source
AI summary
Methods, compositions and kits for detecting the complement Factor B cleavage product Ba in a biological sample are described. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of or ruling out pre-eclampsia in a pregnant human subject.