Multi-Zone Lateral Flow Assays for Antineoplastic Contamination

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Solution Overview

Problem

Existing environmental sampling methods for antineoplastic drugs lack quick and inexpensive ways to identify contamination levels, leading to delayed results and difficulties in distinguishing between varying concentrations due to limited dynamic range in competitive assays.

Innovation Solution

A test system with multiple detection zones on a single test strip, each tuned to different drug concentrations, combined with a reader device for precise analysis, allowing immediate and accurate detection of trace amounts of antineoplastic agents at the site of testing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a single detection zone is used in a competitive assay, then the assay is simple and quick, but the dynamic range is limited and cannot distinguish between varying concentrations accurately

Engineering Contradiction:
Improveconcentration differentiationVSAvoidnumber of detection zones
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The detection zone is segmented into multiple distinct zones (first detection zone, second detection zone, third detection zone) along the lateral flow path, each tuned to detect different concentration ranges of the hazardous drug. This segmentation allows the assay to distinguish between varying concentrations that a single zone cannot resolve, directly addressing the limited dynamic range problem while maintaining the simplicity of the lateral flow format.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The assay transitions from a single-point detection to a multi-point detection along the lateral flow path, adding the spatial dimension of concentration gradient detection. By positioning multiple detection zones at different locations along the flow path, each optimized for different concentration ranges, the system achieves extended dynamic range without requiring complex instrumentation.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Loss of time

If environmental sampling is performed using traditional methods, then contamination can be detected, but results are delayed due to requirement for shipment to outside labs

Engineering Contradiction:
Improveresult receipt timeVSAvoidcontamination level identification
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The assay system performs self-contained detection and quantification of hazardous drugs in environmental samples without requiring external laboratory facilities. The lateral flow assay with multiple detection zones provides immediate on-site results, eliminating shipment delays while maintaining quantitative capability through the multi-zone concentration differentiation.

Inventive Principle:
Principle #25Self-service

3Productivity

If competitive assays are used to detect antineoplastic drugs, then rapid detection is possible, but the inverse relationship curve creates difficulty in distinguishing between concentrations outside the detectable range

Engineering Contradiction:
Improvedetection speedVSAvoidconcentration range distinction
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The competitive assay is segmented into multiple detection zones along the lateral flow path, with each zone tuned to a specific concentration range. This segmentation allows the system to maintain the rapid detection capability of competitive assays while overcoming the inverse relationship curve limitation by providing multiple reference points for concentration differentiation across the full dynamic range.

Inventive Principle:
Principle #1Segmentation

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, quantitative assessment of contamination levels without laboratory delays, providing improved sensitivity and accuracy across a wide range of concentrations, including trace amounts, and reducing exposure risks for healthcare workers.

Implementation Method 1

at least one material configured to wick a liquid sample containing the hazardous contaminant along a lateral flow path

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

a conjugate release zone comprising a plurality of diffusively bound labeled particles configured to be transported along the lateral flow path with the liquid sample

Methodology Applied
Scientific EffectDiffusion: Diffusion

Implementation Method 3

a sensor positioned to receive light reflected from the plurality of detection zones and configured to generate signals representing an intensity of the received light

Methodology Applied
Scientific EffectLight reflection: Reflection

Data Source

PatentUS12436158B2High dynamic range assays in hazardous contaminant testing
Publication Date: 2025.10.07 BECTON DICKINSON & CO
  • US12436158B2 patent drawing
  • US12436158B2 patent drawing
  • US12436158B2 patent drawing

AI summary

Aspects of the disclosure relate to lateral flow assays having a number of different detection zones tuned to extend the dynamic range of the assay in indicating concentration of a hazardous contaminant in a test sample. Some aspects relate to assay reader devices configured with instructions to generate a result representing the concentration of the hazardous contaminant in the test sample based on some or all of the detection zones.