Assay Device Integrated Sample Dilution Verification

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Solution Overview

Problem

Current immunoassay technologies require laboratory settings and trained technicians, leading to increased costs and delayed results, which can be detrimental in critical situations, and there is a need for improved devices that can detect analytes at various levels and perform accurate sample metering for point-of-care testing.

Innovation Solution

The development of immunosensing devices with integrated sample dilution and dilution verification features, using a dilution determinant marker to determine the dilution ratio and calculate analyte concentrations, allowing for real-time or near real-time analysis of analytes in a wide range of dilution ratios from 1:1 to 50,000:1.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If immunoassay tests are performed in a laboratory setting with trained technicians, then measurement precision is improved, but loss of time and productivity are worsened

Engineering Contradiction:

Improveanalyte detection accuracyVSAvoidtime to results

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The assay device performs sample dilution, verification, and analyte detection automatically without requiring trained technicians. The system self-manages the entire analytical process from sample introduction through result generation, enabling point-of-care testing while maintaining measurement precision.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The device incorporates a dilution verification feature that measures the dilution determinant marker concentration to determine the actual dilution ratio. This parameter measurement enables automatic compensation and calculation of analyte concentrations, maintaining accuracy across a wide range of dilution ratios (1:1 to 50,000:1) without manual intervention.

Inventive Principle:

Principle #35Parameter changes

2Measurement precision

If a dilution verification feature is added to determine actual dilution ratio, then measurement precision is improved, but device complexity is worsened

Engineering Contradiction:

Improvedilution ratio determination accuracyVSAvoidassay device structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The dilution verification feature uses the same sensor and measurement capabilities as the analyte detection system. The sensor measures both the dilution determinant marker concentration and the analyte concentration, allowing one measurement system to serve multiple functions without significantly increasing device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

A dilution determinant marker is introduced as an intermediary substance that enables dilution verification. This marker is mixed with the sample before dilution, and its concentration measurement provides information about the actual dilution ratio without requiring complex direct measurement of dilution volume.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Adaptability or versatility

If the device is designed to handle a wide range of dilution ratios, then adaptability is improved, but manufacturing precision requirements are worsened

Engineering Contradiction:

Improvedilution ratio rangeVSAvoidsample metering accuracy

Core Design Contradiction:

Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The system measures the actual dilution ratio by detecting the dilution determinant marker concentration and uses this feedback to calculate the true analyte concentration. This feedback mechanism compensates for variations in sample metering accuracy, allowing the device to handle a wide range of dilution ratios (1:1 to 50,000:1) without requiring extremely precise manufacturing tolerances.

Inventive Principle:

Principle #23Feedback

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 accurate and rapid determination of analytes at the point-of-care, reducing costs and time to results, and effectively handles both low and high-level analyte detection, improving patient outcomes in critical situations.

Implementation Method 1

a dilution element determines a volume of sample for dilution and includes a predetermined known amount of a dilution determinant marker capable of dissolving into the sample

Methodology Applied

Scientific EffectDissolving: Solvation

Implementation Method 2

pumping the diluted sample to a sensor in a sensing region of the cartridge

Methodology Applied

Scientific EffectPumping: Pump

Data Source

PatentUS9933422B2Assay devices with integrated sample dilution and dilution verification and methods of using same

Publication Date: 2018.04.03 ABBOTT POINT OF CARE INC

AI summary

The invention is to devices and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature for forming a diluted sample for analysis. The devices and methods also include a dilution verification feature for verifying the degree of dilution of the diluted sample. The devices preferably are capable of being used in the point-of-care diagnostic field is provided.