Multi-Protein Biomarker Panel for Pre-eclampsia Diagnosis
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Solution Overview
Problem
Current diagnostic methods for pre-eclampsia, such as the PerkinElmer DELFIA Xpress PIGF kit and Alere Triage PLGF test, exhibit low detection rates and high false-positive rates, making them ineffective for clinical diagnosis, and existing genetic analysis methods are inadequate for advanced disease detection.
Innovation Solution
A biomarker composition and kit that measure the expression levels of specific proteins (ANXA3, A2M, APOB, PZP, FETUB, FNI, LCN2, APOM, QSOXI, TGOLN2, FIO, SERPINAII, PRG2, SHBG, TNC, HBD, AGT, CP, HEXB, SERPINA4, and VWF) or their fragments in biological samples, using antibodies, aptamers, or other detection methods, to accurately diagnose pre-eclampsia by comparing expression levels with control samples.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If existing diagnostic kits (PerkinElmer DELFIA Xpress PIGF kit, Alere Triage PLGF test) are used for pre-eclampsia diagnosis, then the diagnostic process is simple and quick, but the detection rate is low (44% at 5% false-positive rate) and clinical effectiveness is insufficient
Solution Approach 1:
The patent segments the diagnostic approach by dividing the analysis into multiple independent protein marker measurements (sFlt-1, PlGF, ANXA3, A2M, APOB, PZP, FETUB, FN1, LCN2, APOM, QSOX1, TGOLN2, F10, SERPINA11, PRG2, SHBG, TNC, HBD, AGT, CP, HEXB, SERPINA4, VWF) rather than relying on a single marker. Each marker is measured separately and integrated to achieve higher diagnostic accuracy while maintaining operational simplicity through automated analysis systems.
Solution Approach 2:
The patent employs a composite diagnostic approach by combining multiple protein marker formulations into a single diagnostic system. The composition includes sFlt-1, PlGF, and at least one additional protein marker from the specified group, creating a composite biomarker profile that leverages the complementary information from each marker to achieve both high detection rate and clinical effectiveness.
2Loss of time
If genetic analysis methods are used for pre-eclampsia detection, then early disease detection is attempted, but the output is inadequate and diagnostic precision is insufficient
Solution Approach 1:
The patent enables preliminary detection of pre-eclampsia by measuring protein marker expression levels in biological samples taken during pregnancy, allowing early identification of at-risk patients before clinical symptoms develop. The method can detect disease risk in advance by analyzing the presence and levels of specific protein markers in maternal blood samples.
Solution Approach 2:
The patent utilizes parameter changes in protein expression levels as indicators of pre-eclampsia risk. By monitoring the concentration and expression levels of specific proteins (such as elevated sFlt-1/PlGF ratio, increased ANXA3, A2M, APOB, PZP, FETUB, FN1, LCN2, APOM, QSOX1, TGOLN2, F10, SERPINA11, PRG2, SHBG, TNC, HBD, AGT, CP, HEXB, SERPINA4, or VWF), the method translates biochemical parameter changes into diagnostic information with high precision.
3Device complexity
If a single protein marker is measured for pre-eclampsia diagnosis, then the test is simple and cost-effective, but the diagnostic accuracy and sensitivity are limited
Solution Approach 1:
The patent segments the diagnostic panel into multiple independent protein marker measurements that can be performed in parallel. The composition specifies sFlt-1, PlGF, and at least one additional marker from a defined group, allowing the diagnostic system to be divided into manageable measurement components while achieving high overall diagnostic accuracy through integration of multiple data points.
Solution Approach 2:
The patent merges multiple protein marker measurements into a unified diagnostic composition and analysis system. By combining the measurement results of sFlt-1, PlGF, and additional protein markers (ANXA3, A2M, APOB, PZP, FETUB, FN1, LCN2, APOM, QSOX1, TGOLN2, F10, SERPINA11, PRG2, SHBG, TNC, HBD, AGT, CP, HEXB, SERPINA4, or VWF) into a single diagnostic assessment, the system achieves enhanced reliability and diagnostic accuracy while managing complexity through integrated analysis.
Data Source
AI summary
Provided are: a composition for diagnosing pre-eclampsia; a kit; a method of diagnosing pre-eclampsia using the same; and a method of providing information on diagnosis of pre-eclampsia. The composition, the kit, and the methods provide the effect of enabling the accurate and sensitive diagnosis of pre-eclampsia in a subject.