Assay Cartridge Structural Member Controls Sample Pretreatment

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Solution Overview

Problem

Current assay methods require additional complexity and risk of errors due to the need for separate pretreatment steps or pretreatment chemistries on membrane pads, which can increase the likelihood of errors and complicate the assay system.

Innovation Solution

A test cartridge design with a structural member that controls the contact between a sample and a sample pad, incorporating a membrane for pretreatment within the cartridge, allowing for filtration, pH adjustment, buffer exchange, and addition of biological chemistries, and actuated by mechanisms such as articulating joints for efficient sample preparation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If separate pretreatment steps or pretreatment chemistries on membrane pads are used, then sample pretreatment can be performed, but the assay system complexity increases and error likelihood increases

Engineering Contradiction:

Improveerror reductionVSAvoidassay system complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the pretreatment membrane and the assay components into a single integrated test cartridge. The membrane is positioned within the cartridge and brought into contact with the sample pad through actuation of a structural member, eliminating the need for separate pretreatment steps or separate membrane pad applications. This integration reduces the number of components and steps, thereby reducing system complexity while maintaining reliable pretreatment function.

Inventive Principle:

Principle #5Merging (Combining)

2Reliability

If multiple separate steps are used for sample pretreatment, then thorough pretreatment can be achieved, but the time required for testing increases

Engineering Contradiction:

Improvepretreatment effectivenessVSAvoidtesting time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The pretreatment membrane is pre-loaded within the test cartridge in a ready-to-use position. When a sample is applied, the membrane is automatically brought into contact with the sample pad through structural member actuation, initiating pretreatment immediately without requiring separate preparation steps. This preliminary positioning and automatic engagement eliminates time-consuming manual steps while ensuring thorough pretreatment is performed.

Inventive Principle:

Principle #10Preliminary action

3Ease of manufacture

If pretreatment chemistries are added separately, then sample pretreatment can be performed, but the number of components and potential error sources increases

Engineering Contradiction:

Improveassay assembly simplicityVSAvoiderror likelihood

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The pretreatment membrane containing chemistries is integrated within the test cartridge as a single component. The membrane is positioned to contact the sample pad through actuation of a structural member, eliminating the need to separately handle and apply multiple pretreatment chemistries. This integration reduces the number of discrete components and potential error sources while maintaining the ability to perform comprehensive sample pretreatment.

Inventive Principle:

Principle #5Merging (Combining)

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 efficient sample pretreatment within the test cartridge, reducing errors and complexity by integrating pretreatment processes, enhancing analyte exposure to test chemistry and minimizing false positives and negatives.

Implementation Method 1

The membrane may comprise trapping agents to be added to the sample, wherein the trapping agents are selected from the group consisting of antibodies, enzymes, precipitating agents, polymers, and any combination thereof

Methodology Applied

Scientific EffectFiltration: Filter (physical)

Implementation Method 2

The membrane pretreatment may be selected from the group consisting of filtration, pH adjustment, viscosity adjustment, buffer exchange, interferent entrapment, addition of biological chemistries such as enzymes or antibodies or antigens

Methodology Applied

Scientific EffectpH adjustment:

Implementation Method 3

Methodology Applied

Scientific EffectBuffer exchange: Osmosis

Implementation Method 4

Methodology Applied

Scientific EffectInterferent entrapment: Adsorption

Implementation Method 5

The structural member may comprise an articulating joint selected from the group consisting of a ball and socket joint, a hinge joint, a living hinge joint, a condyloid joint, a pivot joint, a gliding joint, a saddle joint, spring, and any combination thereof

Methodology Applied

Scientific EffectMechanical actuation: Hinge

Data Source

PatentUS20210362152A1Device for quantifying an assay

Publication Date: 2021.11.25 CORE DIAGNOSTICS CORP

AI summary

The methods and systems disclosed herein may relate to a testing cartridge. A system may include, a test cartridge comprising: a body comprising an upper component and a lower component, an inner cavity at least partially enclosed by the body, a sample port disposed in the upper component, a structural member disposed within the upper component relative to the sample port capable of controlling the contact between a sample and the sample pad, an assay coupled to the lower component, wherein the assay comprises a sample pad, and a membrane coupled to a portion of the structural member capable of pretreating the sample.