Lateral-Flow Test Strip Buffering for Low pH Antibiotic Detection

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Solution Overview

Problem

Traditional lateral-flow test strips are not compatible with low pH fluids, such as citrus juices, which are subject to FDA regulation for antibiotic residues, limiting their effective detection of beta-lactam antibiotics like penicillin.

Innovation Solution

A method and system that involves applying a buffer to raise the pH of a low pH sample, using a test strip with immobilized capture agents and binders to form a binder-analyte complex, allowing for detection of analytes like beta-lactams in citrus juices, with a control zone for comparison to determine positive results.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional lateral-flow test strips are used to detect analytes in low pH samples, then the test structure is simple and easy to operate, but the detection reliability deteriorates due to incompatibility with low pH fluids

Engineering Contradiction:
Improvedetection reliabilityVSAvoidtest system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces a buffer solution as an intermediary substance that mediates between the low pH sample and the test strip. The buffer raises the pH of the sample before it contacts the capture agents on the test strip, creating a compatible environment for detection while allowing the original low pH sample to be tested. This resolves the incompatibility issue without fundamentally changing the test strip structure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent performs preliminary pH adjustment by diluting the low pH sample with buffer before applying it to the test strip. This preliminary action prepares the sample in advance to be compatible with the test strip's capture agents, ensuring reliable detection while maintaining the simplicity of the lateral-flow format.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If traditional lateral-flow test strips are used for low pH samples, then the ease of operation is maintained, but the detection capability for beta-lactam antibiotics deteriorates

Engineering Contradiction:
Improveease of operationVSAvoiddetection capability
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The buffer solution serves as a mediator that enables the test strip to function properly with low pH samples. By raising the pH of the sample before it reaches the capture agents, the buffer allows the test to maintain its simplicity while achieving accurate detection of beta-lactam antibiotics that would otherwise be undetectable.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If pH adjustment is performed before testing, then the detection reliability for low pH samples is improved, but the number of test steps and potential contamination increase

Engineering Contradiction:
Improvedetection reliabilityVSAvoidnumber of test steps
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the pH adjustment function with the sample application step. The buffer is mixed with the sample in the same container where the test strip is applied, merging two functions (pH adjustment and sample application) into a single operation. This reduces the number of separate steps and minimizes contamination risk while maintaining detection reliability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The buffer solution serves multiple functions: it raises the pH of the sample, provides a suitable medium for the capture agents to function, and can be applied directly with the sample. This multi-functionality reduces the need for separate reagents and steps, simplifying the overall test procedure while ensuring reliable detection.

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

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 convenient, efficient, and safe detection of antibiotic residues in low pH samples, including citrus juices, without the limitations of traditional systems, effectively detecting multiple beta-lactams at threshold levels.

Implementation Method 1

raising the pH of the sample by diluting with a buffer to form the solution

Methodology Applied
Scientific EffectpH adjustment through dilution with buffer:

Implementation Method 2

the binder configured for generating a detectable signal and capable of combining with the analyte to form a binder-analyte complex

Methodology Applied
Scientific EffectBinding:

Implementation Method 3

immobilizing, within one or more test zones of the test strip, at least one test zone capture agents capable of capturing the binder

Methodology Applied
Scientific EffectImmobilized capture:

Data Source

PatentUS10247728B1Method and assay for detection of residues
Publication Date: 2019.04.02 CHARM SCIENCES INC
  • US10247728B1 patent drawing
  • US10247728B1 patent drawing
  • US10247728B1 patent drawing

AI summary

Embodiments described herein include detecting an analyte in a low pH sample. Some embodiments include detection of multiple analytes in a sample utilizing a plurality of analyte binders and a control zone containing multiple control zone capture agents. In some embodiments, the multiple control zone capture agents capture a plurality of binders within one control zone.