Split Flow Device for One-Step Signal Amplification

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Solution Overview

Problem

Lateral flow strip-based assays for analyte detection in biological samples are limited by their sensitivity due to the requirement for multiple steps to achieve signal amplification, which complicates the detection process.

Innovation Solution

The analyte detection system employs a dual flow path system where a secondary flow path delivers reagents to the capture region after the analyte-conjugate complex is captured, allowing for one-step amplification of the detection signal without the need for additional washing or substrate application steps.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If enzyme label conjugates are used for signal amplification, then detection sensitivity is improved, but the assay requires multiple steps including washing and substrate delivery

Engineering Contradiction:
Improvedetection sensitivityVSAvoidassay steps
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines the capture region and substrate delivery function into a single integrated region. The capture membrane contains both the capture protein for analyte binding and the enzyme substrate, eliminating the need for separate washing and substrate delivery steps. This merging of functions allows signal amplification to occur in one step while maintaining high detection sensitivity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The capture region is designed to perform multiple functions simultaneously: it captures the analyte-conjugate complex, provides the enzyme substrate for signal amplification, and eliminates the need for separate washing steps. This multi-functional design reduces assay complexity while maintaining sensitivity.

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

2Measurement precision

If nanoparticle-based signal intensification is used, then detection sensitivity is improved, but the assay requires several steps to wash unreacted conjugate and apply intensification solution

Engineering Contradiction:
Improvedetection sensitivityVSAvoidassay steps
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent merges the substrate delivery function with the capture region, so that the intensification reagents are delivered directly to where the analyte-conjugate complex is captured. This eliminates the need for separate washing steps and reduces the overall number of assay steps while maintaining signal intensification capability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The capture membrane acts as an intermediary that simultaneously performs analyte capture and reagent delivery. By incorporating the enzyme substrate into the capture membrane, the system mediates both functions in a single component, simplifying the assay procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If a single flow path is used, then the assay is simple and rapid, but signal amplification cannot be achieved

Engineering Contradiction:
Improveassay speedVSAvoiddetection sensitivity
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent merges the substrate delivery function into the capture region, allowing a single flow path to perform both analyte capture and signal amplification. This eliminates the need for multiple flow paths or complex multi-step procedures while maintaining the ability to achieve signal amplification.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The enzyme substrate is pre-loaded into the capture region membrane, so that when the analyte-conjugate complex is captured, the substrate is already in position for immediate signal amplification. This preliminary preparation allows rapid one-step detection without requiring subsequent substrate delivery steps.

Inventive Principle:
Principle #10Preliminary action

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

This approach enables sensitive, one-step detection of analytes by ensuring that reagents are delivered sequentially to the capture region, enhancing the detection sensitivity and simplifying the process while maintaining accurate results.

Implementation Method 1

The complex continues to migrate through the porous membrane to the region where the capture protein is immobilized

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

In another embodiment, the substrate entry region comprises a semi-permeable membrane

Methodology Applied
Scientific EffectSemipermeable membrane filtration: Semipermeable Membrane

Data Source

PatentUS8377643B2Split flow device for analyses of specific-binding partners
Publication Date: 2013.02.19 ZOETIS SERVICES LLC
  • US8377643B2 patent drawing
  • US8377643B2 patent drawing
  • US8377643B2 patent drawing

AI summary

The present invention provides an analyte detection system for detecting a target analyte in a sample. In particular, the invention provides a detection system capable of one-step amplification of the detection signal by incorporating a secondary flow path that can deliver reagents to a reaction zone. Methods of using the detection system to detect analytes in samples, particularly biological samples, and kits comprising the detection system are also disclosed.