Point-of-Care Preeclampsia Screening With Lateral-Flow Urine Tests
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Solution Overview
Problem
Current diagnostic methods for preeclampsia require clinical settings and lack home-based or point-of-care solutions, leading to delayed detection and high maternal mortality, especially in resource-limited settings.
Innovation Solution
Development of point-of-care diagnostic devices and methods using lateral-flow immunoassays to detect activin A and/or inhibin A in urine samples, providing early detection of preeclampsia through test strips that can be used at home or in any care location.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If current clinical diagnosis methods (blood pressure measurement and urine protein dipstick) are used, then preeclampsia can be diagnosed, but early detection is delayed and requires clinical settings, leading to high maternal mortality especially in resource-limited settings
Solution Approach 1:
The patent extracts the essential diagnostic function from complex clinical settings by developing a simplified point-of-care test device that measures activin A and inhibin A biomarkers directly at the patient location, eliminating the need for hospital-based equipment and procedures
Solution Approach 2:
The test device enables patients to perform self-diagnosis at home or in community settings by collecting urine samples and obtaining results without requiring healthcare provider intervention, thereby improving accessibility and reducing detection delays
2Ease of operation
If point-of-care diagnostic devices using lateral-flow immunoassays are developed, then accessibility to early detection is improved, but device complexity and manufacturing challenges increase
Solution Approach 1:
The patent combines multiple diagnostic functions into a single integrated lateral-flow test device that simultaneously detects both activin A and inhibin A biomarkers, reducing the need for multiple separate tests while maintaining diagnostic accuracy
Solution Approach 2:
The patent optimizes the immunoassay parameters including antibody selection, conjugate formulation, and membrane properties to achieve reliable detection at point-of-care settings, balancing sensitivity requirements with device simplicity and manufacturing feasibility
3Reliability
If current diagnosis methods are used, then established protocols can be followed, but specificity and sensitivity for early detection are insufficient, leading to missed diagnoses
Solution Approach 1:
The patent replaces the subjective visual assessment of urine protein dipsticks with an objective immunoassay-based quantitative measurement of activin A and inhibin A biomarkers, significantly improving measurement precision and diagnostic reliability
Solution Approach 2:
The patent introduces specific antibodies as intermediaries that selectively bind to activin A and inhibin A biomarkers, enabling precise detection and differentiation of these disease-specific markers from other pregnancy-related substances
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 detection of preeclampsia with specificity and sensitivity of 75-95% and 50-70%, allowing for timely medical intervention and reducing severe health impacts.
Implementation Method 1
point-of-care diagnostic devices and methods using lateral-flow immunoassays to detect activin A and/or inhibin A in urine samples
Implementation Method 2
a test antibody with an affinity to activin A and/or inhibin A
Implementation Method 3
a chromatography matrix
Data Source
AI summary
Provided are diagnostic and/or screening tests, assays and devices for preeclampsia (PE). The diagnostic and/or screening tests, assays and devices include test antibodies for activin A and/or inhibin A. The PE diagnostic and/or screening tests, assays and devices are capable of detecting activin A and/or inhibin A in a sample at a concentration of less than about 60 pg/mL. Corresponding methods of diagnosing and/or screening for PE are provided.