Self-Metering Bioassay Cartridge for Multiplexed Point-of-Care Detection

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Solution Overview

Problem

Existing point-of-care testing devices for viral diseases are bulky, complex, and costly, requiring specialized training and high sample preparation time, making them unsuitable for resource-poor settings.

Innovation Solution

A self-metering cartridge with microfluidic devices for rapid, low-cost point-of-care bioassays, featuring a lysis buffer chamber, sample chamber, and two detection chambers, along with a multi-use appliance providing thermal sources, pressure sources, light sources, optical detectors, and optical occluders, enabling multiplexed bioassays using fluorescent labels and optical occluders for efficient biomolecule detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If real-time PCR tests are used for accurate viral load assessment, then measurement precision is improved, but device complexity and sample preparation time increase

Engineering Contradiction:

Improveviral load assessment accuracyVSAvoidreagent handling protocol complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The device is divided into distinct functional modules: a sample processing module with lysis buffer chamber, an amplification module with detection chambers, and a reading module with optical detectors. Each module handles specific tasks independently, simplifying the overall complex process while maintaining accuracy.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The appliance is designed as a multi-use device that can perform multiple functions: thermal cycling for amplification, optical detection for measurement, and fluid handling for sample processing. This consolidates what would otherwise require multiple separate instruments into a single device.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Measurement precision

If real-time PCR tests are used for accurate viral load assessment, then measurement precision is improved, but loss of time increases

Engineering Contradiction:

Improveviral load assessment accuracyVSAvoidsample preparation time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

Reagents are pre-loaded into the cartridge in dried form, and the cartridge is pre-assembled with all necessary components. This eliminates the need for complex real-time reagent preparation and handling during the testing process, significantly reducing sample preparation time while maintaining assay accuracy.

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If point of care testing devices are simplified for ease of operation, then ease of operation is improved, but measurement precision may deteriorate

Engineering Contradiction:

Improvetraining requirementVSAvoidbioassay accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The cartridge is designed as a self-contained, self-metering system that automatically handles fluid dispensing, mixing, and sample processing without requiring external intervention or complex user operations. This self-service design maintains laboratory-grade precision while enabling use by personnel with minimal training.

Inventive Principle:

Principle #25Self-service

4Ease of manufacture

If existing point of care devices are made less costly, then manufacturing cost is reduced, but device complexity may increase

Engineering Contradiction:

Improvedevice costVSAvoidassay cartridge structure

Core Design Contradiction:

Ease of manufactureVSDevice complexity

Solution Approach 1:

The assay is performed in a disposable cartridge that is pre-filled with reagents and discarded after a single use. This eliminates the need for expensive, complex, and reusable components that require maintenance and calibration, significantly reducing device cost while maintaining assay precision through factory-prepared standardized reagents.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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, accurate, and cost-effective detection of biomolecules like polynucleotides in a single cartridge using a single appliance, overcoming the limitations of existing devices by simplifying sample preparation and reducing the need for specialized training.

Implementation Method 1

positioning an optical occluder in a first position to block the second detection chamber from at least a portion of the first wavelength of light

Methodology Applied

Scientific EffectOptical occlusion: Absorption (EM radiation)

Implementation Method 2

illuminating the first detection chamber induces fluorophore 1A of the first amplified biomolecule to produce emitted light signal 1A

Methodology Applied

Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS20250389715A1Point-of-care bioassay systems and methods of making and using the same

Publication Date: 2025.12.25 AMPLIFIDX INC

AI summary

Devices and methods for performing rapid low-cost bioassays, including some embodiments for multiplexed detection of multiple amplified biomolecules for identifying one or more diseases, disorders, or infections, are disclosed herein. Such methods can include isolating a first biomolecule in a first detection chamber, isolating a second biomolecule in a second detection chamber, illuminating the first detection chamber with a first light source, and illuminating the second detection chamber with a second light source, where the illumination induces the production of an emitted light signal.