Sequential Home Pregnancy Test System for hCG Progression Tracking
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Solution Overview
Problem
Conventional home pregnancy tests do not effectively confirm viable pregnancy progression and can produce false positives or negatives, lacking a simple method to determine if a pregnancy is progressing or if a miscarriage has occurred, as they rely on variable sensitivity and do not account for changes in hCG levels over time.
Innovation Solution
A system of tests with decreasing sensitivity, where users take tests every two days to track increasing hCG levels, with positive results indicating pregnancy progression, and optional progesterone tests providing additional confirmation of viable pregnancy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single home pregnancy test is used, then the test can be performed at home with simple operation, but it cannot confirm pregnancy progression or viability
Solution Approach 1:
The pregnancy testing process is segmented into multiple sequential tests performed at different time points (e.g., day 1, day 3, day 5). Each test provides a data point, and the sequence of results together confirm pregnancy progression. This segmentation transforms a single static test into a dynamic progression assessment while maintaining home testing simplicity.
Solution Approach 2:
The system provides preliminary instructions and planning for multiple tests before the actual testing begins. Users are given a testing schedule and guidance on what to expect at each stage, allowing them to prepare mentally and logistically for the progression testing protocol, thereby maintaining ease of operation throughout the process.
2Adaptability or versatility
If conventional home pregnancy tests with variable sensitivity are used, then the tests are available with different detection thresholds, but false positives and negatives occur
Solution Approach 1:
The system uses feedback from sequential test results to confirm pregnancy progression. Instead of relying on a single test result, the system requires a pattern of increasing positive results across multiple tests. This feedback mechanism filters out false positives and negatives by requiring consistent progression, thereby improving reliability while maintaining the adaptability of different sensitivity levels.
Solution Approach 2:
The system changes the parameter being measured from a single hCG detection threshold to a progression pattern across multiple time points. By focusing on the change in hCG levels over time rather than a single absolute value, the system overcomes the reliability issues associated with variable test sensitivities, as the progression pattern is more consistent across different sensitivity levels.
3Measurement precision
If serial quantitative hCG levels are measured to confirm pregnancy viability, then pregnancy progression can be accurately tracked, but physician and phlebotomy services are required
Solution Approach 1:
The system enables self-service pregnancy progression testing by using home urine test kits instead of requiring physician visits and blood draws. Users independently perform multiple tests according to a provided schedule, collect their own samples, and interpret results using simple guidance materials. This maintains measurement precision for progression tracking while eliminating the need for complex medical infrastructure.
Solution Approach 2:
The system uses disposable home pregnancy test strips or devices that are inexpensive and single-use. Rather than requiring expensive, reusable laboratory equipment or ongoing medical services, the system employs multiple disposable home tests that can be discarded after use. This reduces device complexity and makes precise hCG progression tracking accessible at home.
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 method allows users to confidently assess pregnancy progression by tracking hCG levels over time, reducing false positives and negatives, and providing a clear indication of viable pregnancy through sequential testing.
Implementation Method 1
all pregnancy tests work on the multi-antibody immunometric assay principal: commonly one and occasionally two antibodies (mono- or polyclonal) binds and immobilizes hCG and a second antibody, the tracer antibody, raised to a distant (different) epitope and labeled with an enzyme, dye or chemiluminescence agent, marks the presence of hCG or quantitates hCG present in the sample
Data Source
AI summary
A pregnancy progression test system that includes multiple tests, each with decreasing sensitivity to provide the user of indication of a progressing pregnancy when taken over the course of a time period.