HPV Copy Number Assessment via Standard Curve Amplification

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Solution Overview

Problem

Current methods for detecting human papillomavirus (HPV) are laborious, time-consuming, and lack clear distinction between high- and low-risk types, with existing molecular diagnostic techniques being unsuitable for clinical use due to low sensitivity and high throughput limitations.

Innovation Solution

A method and kit for assessing copy number of a target polynucleotide in a sample using a standard curve established through control amplification reactions, allowing for accurate detection of HPV by correlating signal strength with copy number, enabling precise identification of HPV types.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional Pap smear or conventional HPV detection methods are used, then the detection process is simple to perform, but the sensitivity and ability to distinguish high- and low-risk HPV types are insufficient

Engineering Contradiction:
ImproveHPV detection sensitivity and type differentiationVSAvoiddetection method complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the detection process into multiple independent components: separate primer pairs for different HPV types, individual amplification reactions for each target, and separate detection steps. This allows high sensitivity and type differentiation while maintaining procedural simplicity through modular design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses parameter changes in the form of specific primer sequences optimized for different HPV types, varying amplification conditions, and specific signal detection parameters. This enables precise differentiation between high- and low-risk types while keeping the overall method straightforward.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If molecular diagnostic techniques with high sensitivity are used, then accurate HPV detection is achieved, but the methods are laborious and time-consuming

Engineering Contradiction:
ImproveHPV detection accuracyVSAvoiddetection time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent performs preliminary actions by pre-designing and optimizing primer pairs for multiple HPV types, preparing standardized amplification protocols, and establishing predetermined detection thresholds. This preliminary preparation enables rapid, accurate detection without time-consuming optimization during actual testing.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements continuous useful action through a streamlined workflow where DNA extraction, amplification, and detection proceed in continuous steps without interruption. The method maintains high accuracy while reducing total detection time by eliminating unnecessary intermediate steps.

Inventive Principle:
Principle #20Continuity of useful action

3Productivity

If conventional HPV detection methods are used, then the procedure is easy to perform, but the throughput is low and cannot meet clinical screening demands

Engineering Contradiction:
Improvedetection throughputVSAvoidoperational simplicity
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The patent creates a universal detection system that can identify multiple HPV types (both high-risk and low-risk) using a standardized protocol. This multi-functional approach increases throughput by allowing simultaneous detection of various HPV types in a single assay while maintaining ease of operation through a unified procedure.

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

Solution Approach 2:

The patent merges multiple detection capabilities into a single integrated assay system. By combining primers and detection protocols for different HPV types into one unified method, it achieves high throughput clinical screening capability while preserving operational simplicity through consolidation rather than multiple separate tests.

Inventive Principle:
Principle #5Merging (Combining)

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 method and kit provide high sensitivity, specificity, and reliability for HPV detection, enabling accurate differentiation between high- and low-risk HPV types, facilitating early cervical cancer screening and treatment.

Implementation Method 1

conducting a control amplification reaction on the multiple copy number control compositions and the quantity control polynucleotide to amplify the target polynucleotide in the multiple copy number control compositions and the quantity control polynucleotide

Methodology Applied
Scientific EffectPCR amplification:

Data Source

PatentUS9994922B2Methods and compositions for assessing copy number of target polynecleotides
Publication Date: 2018.06.12 NINGBO HEALTH GENE TECHNOLOGIES CO LTD
  • US9994922B2 patent drawing
  • US9994922B2 patent drawing
  • US9994922B2 patent drawing

AI summary

The present invention relates to methods and compositions for assessing copy number of a target polynucleotide in a sample, methods and compositions for establishing a standard curve for a target polynucleotide, and the uses of the methods and compositions for detecting a pathogen, e.g., human papillomavirus (HPV).