Paper-Based Microarray Chip for Rapid HPV Detection

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Solution Overview

Problem

Current molecular diagnostic techniques for HPV detection require expensive equipment, skilled personnel, and lengthy turnaround times, making them unsuitable for resource-limited settings, while rapid diagnostic tests suffer from low sensitivity and specificity.

Innovation Solution

A paper-based, portable diagnostic device integrating nucleic acid extraction, amplification, and detection using a paperfluidic chip with a capture region, waste region, and detection region, enabling rapid, point-of-care nucleic acid testing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If molecular diagnostic techniques are used for HPV detection, then sensitivity and specificity are improved, but cost and equipment requirements increase

Engineering Contradiction:
Improvedetection sensitivityVSAvoidequipment sophistication
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs disposable microarray chips with pre-immobilized capture probes that can be discarded after a single use. This eliminates the need for expensive, complex instrumentation by using low-cost, single-use diagnostic units that integrate sample processing and detection, thereby maintaining high sensitivity while reducing device complexity and cost.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent extracts the complex instrumentation requirements from the detection system and replaces them with simplified sample-to-answer cartridges. The microarray chip design separates capture, detection, and waste regions into distinct functional zones, allowing the removal of sophisticated laboratory equipment while preserving diagnostic accuracy through integrated on-chip processing.

Inventive Principle:
Principle #2Taking out (Extraction)

2Measurement precision

If molecular diagnostic techniques are used for HPV detection, then detection accuracy is improved, but turnaround time increases

Engineering Contradiction:
Improvedetection accuracyVSAvoidturnaround time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent merges multiple diagnostic steps (sample preparation, nucleic acid amplification, and detection) into a single integrated microarray chip workflow. By combining these functions in one device with automated fluid handling and on-chip processing, the system achieves both high detection accuracy and rapid results, reducing turnaround time while maintaining molecular-level diagnostic precision.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent implements continuous automated processing through the microarray chip design, where sample lysis, nucleic acid release, hybridization, and detection occur in continuous sequence without manual intervention or waiting periods. This continuous action eliminates idle time between steps, maintaining high detection accuracy while significantly reducing overall turnaround time.

Inventive Principle:
Principle #20Continuity of useful action

3Measurement precision

If molecular diagnostic techniques are used for HPV detection, then sensitivity is improved, but resource requirements increase

Engineering Contradiction:
Improvetest sensitivityVSAvoidlaboratory infrastructure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent uses disposable microarray chips that eliminate the need for expensive, maintainable laboratory infrastructure. Each chip is a low-cost, single-use unit that performs high-sensitivity detection without requiring sophisticated equipment, thereby reducing resource requirements while maintaining high test sensitivity through integrated on-chip processing.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The microarray chip design enables self-service operation where the chip itself performs sample processing, nucleic acid amplification, and detection without requiring external sophisticated equipment or highly trained personnel. The chip's integrated design handles all complex functions autonomously, reducing resource requirements while maintaining high sensitivity through built-in capture and detection mechanisms.

Inventive Principle:
Principle #25Self-service

4Speed

If rapid diagnostic tests are used, then speed is improved, but sensitivity and specificity deteriorate

Engineering Contradiction:
Improvedetection speedVSAvoidtest specificity
Core Design Contradiction:
SpeedVSMeasurement precision

Solution Approach 1:

The patent changes the detection parameter from traditional immunochromatographic methods to nucleic acid hybridization on microarrays. This parameter change enables rapid detection speed through automated on-chip processing while maintaining high specificity through sequence-specific probe hybridization, overcoming the limitation of conventional rapid tests that sacrifice accuracy for speed.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the mechanical reading systems of traditional rapid tests with optical detection of fluorescent or chemiluminescent signals from nucleic acid hybridization. This substitution maintains rapid detection speed while dramatically improving specificity through molecular-level recognition, allowing visual or automated readout of highly specific nucleic acid-probe interactions.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 device provides a low-cost, rapid, and sensitive molecular diagnostic platform for HPV detection, overcoming resource limitations and improving access to early disease detection, reducing mortality in resource-constrained settings.

Implementation Method 1

The capture region can be any material that can bind a target in a sample, such as, but not limited to, a porous membrane (e.g., polyethersulfone (PES), glass fiber, cellulose paper, polycarbonate membrane, or other polymer or natural material-based porous membrane)

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

The sample can then be wicked out of the capture region into the waste region

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Data Source

PatentUS11136620B2Detection device having capture region and detection region
Publication Date: 2021.10.05 TRUSTEES OF BOSTON UNIV
  • US11136620B2 patent drawing
  • US11136620B2 patent drawing
  • US11136620B2 patent drawing

AI summary

The invention features a fully-integrated rapid molecular diagnostic device that is low-cost, easy to manufacture, and simple to use. The device can serve as a molecular diagnostic platform for any disease, requiring little or no preparation or customization and can be made from simple materials (e.g., paper and adhesive film), making it inexpensive, portable, and disposable. The invention also provides methods of using the device for detection of one or more targets in a sample.