In Vitro Diagnostic Device with Piercing Plunger for Rapid Strep Testing
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for diagnosing pharyngitis or Group A strep infections in children are time-consuming and costly, often requiring multiple clinic visits and expensive tests, with many rapid tests yielding negative results, leading to unnecessary follow-up procedures.
Innovation Solution
An in vitro diagnostic device comprising a plunger, housing, reagent pouches, and a lateral flow test strip, which allows for at-home testing by piercing reagent pouches to mix extraction solutions, inserting a test swab, and using a lateral flow test strip to detect analytes like Group A Streptococcus bacteria, providing rapid and accurate results.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If rapid-test diagnosis is performed at clinic, then diagnosis speed is improved, but test accuracy and reliability deteriorate due to high false negative rate (80% negative results with follow-up needed)
Solution Approach 1:
The patent uses a lateral flow test strip that creates a visual copy of the detection result through line appearance on a membrane, allowing rapid interpretation without requiring complex equipment or clinician presence, thereby maintaining both speed and reliability at home
Solution Approach 2:
The patent replaces the mechanical clinic-based testing system with a chemical immunoassay system that uses antibody-antigen binding reactions to detect Group A Streptococcus, enabling accurate results without requiring physical examination or clinician involvement
2Measurement precision
If culture-based test is performed, then measurement precision is improved, but loss of time increases due to multiple clinic visits and follow-up procedures
Solution Approach 1:
The patent performs all necessary reagent preparation and test setup actions in advance within the sealed device, including pre-mixed extraction solutions and pre-positioned test strips, allowing immediate accurate testing at home without requiring subsequent clinic visits for result interpretation or follow-up
Solution Approach 2:
The device enables self-service testing where the consumer can independently complete the entire diagnostic process from sample collection to result interpretation without requiring clinic staff, thereby eliminating time loss from multiple visits while maintaining culture-based test precision
3Reliability
If multiple clinic visits are required for diagnosis and treatment, then reliability of diagnosis is improved, but device complexity and cost increase
Solution Approach 1:
The patent merges multiple separate functions into a single integrated device: sample collection, reagent storage, extraction, lateral flow testing, and result interpretation all occur within one self-contained unit, eliminating the need for multiple clinic visits and reducing overall system complexity despite maintaining high diagnostic reliability
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 rapid, cost-effective, and accurate at-home testing for Group A Streptococcus bacteria, reducing the need for multiple clinic visits and expensive tests, allowing for timely and appropriate treatment without burdensome medical facility visits.
Implementation Method 1
a piercing member that is open in the middle to enable fluid communication with the interior and that has a smaller cross-sectional area than that bounded by the one or more plunger sidewalls
Implementation Method 2
a lateral flow test strip disposed in the test strip channel
Data Source
AI summary
A method of identifying the presence of an analyte may include providing an in vitro test device and a test swab; obtaining a sample using the test swab; transitioning the locking member from the first configuration to the second configuration; advancing the plunger into the housing to pierce the one or more reagent pouches in the reagent region to cause reagent therein to be released and mix; inserting the test swab with obtained sample into the interior of the plunger; rotating the in vitro test device and disposing it on its plunger base; and determining whether the analyte is present. The in vitro test device may include a plunger, a housing, one or more reagent pouches disposed in the housing, a lateral flow test strip, and a locking member having configurations that either allow or prevent reagent in the one or more reagent pouches from being released.