Modular Microfluidic Testing Device for Molecular Diagnostics

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Solution Overview

Problem

Current at-home and point-of-care diagnostic testing devices are limited in their ability to perform molecular tests efficiently and cost-effectively for a wide range of pathogens, including COVID-19, in various settings such as clinical and field environments, requiring improved modular and affordable solutions for sample processing and target molecule detection.

Innovation Solution

The development of modular, low-cost testing devices that include a sample chamber, reagent reservoir, fluidic lines, and a diagnostic indicator, utilizing a pump and heater to mix samples and reagents within a common fluidic line with a passive mixer, enabling timely and accurate detection of multiple target molecules through methods like LAMP or PCR, and allowing for both single and multi-target testing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If conventional testing devices are used, then testing capability is provided, but cost and complexity are high and scalability is limited

Engineering Contradiction:
Improvemanufacturing costVSAvoiddevice complexity
Core Design Contradiction:
Ease of manufactureVSDevice complexity

Solution Approach 1:

The testing device is divided into separate functional modules: a sample processing module with sample chamber and fluidic lines, a reagent delivery module with reservoir and pump, a detection module with diagnostic indicator, and a control module. This segmentation allows each module to be manufactured independently at lower cost and simplifies overall device assembly and maintenance.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device is designed with universal interfaces and standardized components that can be configured to perform multiple testing functions. The same basic architecture supports different sample types (nasal swab, saliva, urine) and can be adapted for various pathogens through modular reagent cartridges, reducing overall device complexity while maintaining versatility.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Ease of manufacture

If modular low-cost design is implemented, then manufacturing cost decreases, but testing accuracy and reliability may be compromised

Engineering Contradiction:
Improvemanufacturing costVSAvoidtesting accuracy
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The device replaces complex mechanical mixing and heating systems with microfluidic integrated channels that use pressure-driven flow and thermal elements. The pump system uses peristaltic or diaphragm mechanisms that are simpler and more reliable than traditional syringe pumps, while maintaining precise fluid delivery for accurate testing.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Loss of time

If rapid testing is performed, then time to result decreases, but processing capacity for multiple samples is limited

Engineering Contradiction:
Improvetime to resultVSAvoidprocessing capacity
Core Design Contradiction:
Loss of timeVSProductivity

Solution Approach 1:

The device incorporates parallel processing capability with separate fluidic channels and detection indicators that can simultaneously process multiple samples. The modular architecture allows multiple test reactions to occur in parallel within the same device, enabling rapid individual testing while maintaining high throughput capacity for dozens to hundreds of samples.

Inventive Principle:
Principle #1Segmentation

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

These devices enable rapid, cost-effective, and accurate molecular testing for various pathogens, including COVID-19, in at-home and point-of-care settings, processing dozens to hundreds of samples efficiently and providing timely results, with the ability to detect multiple targets using additional reagents and indicators.

Implementation Method 1

a pump that is used to urge the sample through the sample fluidic line and toward the common fluidic line and urge the reagent(s) through the reagent fluidic line and toward the common fluidic line

Methodology Applied
Scientific EffectPressure-driven flow: Pressure Gradient

Implementation Method 2

a heater is used to heat one or more of the sample fluidic line, the reagent fluidic line, or the common fluidic line

Methodology Applied
Scientific EffectThermal heating: Heating

Implementation Method 3

The common fluidic line may include a passive mixer such as a herringbone mixer that is used to mix the sample, buffer, and reagent together

Methodology Applied
Scientific EffectPassive mixing: Turbulence

Data Source

PatentUS20240226876A1Testing devices
Publication Date: 2024.07.11 CZ BIOHUB SF LLC
  • US20240226876A1 patent drawing
  • US20240226876A1 patent drawing
  • US20240226876A1 patent drawing

AI summary

Testing devices are disclosed. In accordance with a first implementation, a testing device includes a sample chamber is to receive a sample and a reagent reservoir that contains a reagent used to determine a presence of a target molecule in the sample. A sample fluidic line is fluidically coupled to the sample chamber and a common fluidic line and a reagent fluidic line is fluidically coupled to the reagent reservoir and to the common fluidic line. A diagnostic indicator is coupled to the common fluidic line. The sample and the reagent flow through the respective sample fluidic line and the reagent fluidic line toward the common fluidic line and form a mixture within the common fluidic line and the common fluidic line enables a threshold incubation period of the mixture prior to the mixture flowing to the diagnostic indicator.