Lateral Flow Immunoassay System with Integrated Buffer Vial

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Solution Overview

Problem

Current point-of-care screening tests for body fluids, particularly saliva, face challenges due to the high viscosity of saliva and the presence of mucins, which disrupt capillary flow and inhibit accurate and rapid test results, requiring elaborate pre-treatment procedures outside the testing device.

Innovation Solution

A lateral flow immunoassay system with a housing that includes a buffer vial and a sample collector, allowing for the treatment and incubation of the test sample with a buffer agent to break down mucins, thereby facilitating precise control of sample fluid and reagent flow, and enabling quick and accurate testing of analytes like drugs of abuse in saliva and other body fluids.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If lateral flow immunoassay is used for rapid on-site testing, then testing speed and convenience are improved, but accuracy and reliability deteriorate due to lack of professional control and potential for incorrect interpretation

Engineering Contradiction:
Improvetesting speedVSAvoidtest accuracy
Core Design Contradiction:
SpeedVSReliability

Solution Approach 1:

The patent introduces a buffer agent as an intermediary substance that mediates between the sample and the immunoassay test strip. The buffer agent breaks down mucins in saliva samples, preventing them from interfering with the test results. This intermediary component enables non-laboratory personnel to obtain accurate results without professional training, as the buffer agent automatically corrects sample quality issues.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent performs preliminary treatment of the sample by incorporating a buffer agent that pre-breaks down mucins before the actual immunoassay testing occurs. This preliminary action ensures that the sample is properly prepared and free from interfering substances before it contacts the test strip, thereby guaranteeing accurate results while maintaining rapid testing capability.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If saliva is used as test sample for on-site testing, then ease of sample collection is improved, but test accuracy deteriorates due to high viscosity and presence of mucins that disrupt capillary flow

Engineering Contradiction:
Improvesample collection easeVSAvoidcapillary flow accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The buffer agent serves as an intermediary that chemically modifies the saliva sample by breaking down mucins. This modification reduces the viscosity and eliminates the interfering properties of mucins, allowing capillary flow to proceed accurately through the test strip despite the initial poor quality of the saliva sample.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the chemical parameters of the saliva sample by introducing a buffer agent that alters the sample's composition. The buffer agent breaks down mucins, thereby changing the viscosity and flow properties of the sample to enable proper capillary action through the immunoassay strip.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If pre-treatment procedures are performed outside the testing device to break down mucins, then sample quality is improved, but device complexity and procedural steps increase

Engineering Contradiction:
Improvesample qualityVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the pre-treatment function (breaking down mucins) with the testing device itself by incorporating the buffer agent into the device. The buffer agent is contained within the device and is automatically mixed with the sample, eliminating the need for separate pre-treatment steps outside the device. This integration maintains sample quality while simplifying the overall procedure.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device performs self-service by automatically providing the buffer agent to treat the sample. The user simply adds the sample to the device, and the buffer agent automatically breaks down mucins as part of the testing process. This self-service mechanism eliminates the need for users to perform complex pre-treatment procedures, reducing procedural complexity while ensuring sample quality.

Inventive Principle:
Principle #25Self-service

4Speed

If buffer agent is added to break down mucins, then capillary flow is improved, but device complexity increases due to additional components

Engineering Contradiction:
Improvecapillary flow speedVSAvoiddevice structure
Core Design Contradiction:
SpeedVSDevice complexity

Solution Approach 1:

The patent implements a nested structure where the buffer agent is contained within a buffer vial that is integrated into the device housing. The buffer vial is positioned to allow automatic dispensing of the buffer agent into the sample well. This nested arrangement minimizes the external footprint of the device while incorporating the additional buffer component, thereby improving capillary flow speed without significantly increasing overall device complexity.

Inventive Principle:
Principle #7Nested doll (Nesting)

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

The system provides a safe, efficient, and accurate mechanism for on-site testing of analytes, ensuring precise control of sample and reagent flow, enhancing sensitivity and speed of test results while minimizing user intervention and contact with the specimen.

Implementation Method 1

treated and incubated for a desired period of time prior to being introduced to an immunoassay test strip

Methodology Applied
Scientific EffectChemical decomposition: Decomposition (biological)

Implementation Method 2

lateral flow test, which uses a membrane or paper strip to indicate the presence of protein markers such as pathogen antigens or host antibodies

Methodology Applied
Scientific EffectImmunoassay binding reaction: Adsorption

Implementation Method 3

addition of sample induces capillary action without user intervention (leveraging capillary forces for fluid actuation)

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentEP3117213B1System and method for lateral flow immunoassay testing
Publication Date: 2019.05.08 AMERICAN BIO MEDICA CORP
  • EP3117213B1 patent drawingFigure 1
  • EP3117213B1 patent drawingFigure 2
  • EP3117213B1 patent drawingFigure 3

AI summary

A lateral flow immunoassay system is provided that includes a housing having a base portion forming a first chamber therein and a body portion formed with three openings in fluid communication with the first chamber, a vial containing a buffer agent, and a sample collector for introducing a sample fluid into the first chamber via the second opening. The vial is mounted to the housing such that a dispensing side extends into the first opening for dispensing the buffer agent therefrom into the first chamber. The housing allows the buffer agent and sample fluid to be mixed within a reaction well formed within the first chamber to form a test sample mixture. The body portion is configured to receive a receiving end of an elongated holder in the third opening and allow a test strip secured in the holder to be brought into communication with the text sample mixture.