HPV Detection Oligomers for High-Risk Strain Sensitivity

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Solution Overview

Problem

Current methods for detecting human papillomavirus (HPV) in biological specimens lack efficiency and sensitivity, particularly for high-risk HPV types and in vaccinated individuals, necessitating improved diagnostic and prognostic tools for cervical cancer screening and monitoring.

Innovation Solution

The development of specific oligomer sequences and assays that amplify and detect HPV nucleic acid sequences, including those for high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68, using a mixture of amplification oligomers and detection probes, which are designed to target the E6/E7 gene sequences and minimize adverse interactions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current HPV detection methods are used, then detection can be performed, but sensitivity and efficiency are insufficient particularly for high-risk HPV types

Engineering Contradiction:
Improvedetection sensitivityVSAvoiddetection efficiency
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The invention divides the detection system into multiple specific oligomer sequences, each targeting different high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68). This segmentation allows each oligomer to be optimized for its specific target, improving overall detection sensitivity and reliability for high-risk types

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The assay system serves multiple functions: it detects various high-risk HPV types simultaneously, provides diagnostic information, offers prognostic value, and monitors vaccination efficacy. This multi-functionality resolves the contradiction by making a single detection system capable of handling diverse detection needs with high sensitivity and efficiency

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

2Measurement precision

If current detection assays are used, then general HPV detection is possible, but they lack sensitivity in vaccinated individuals

Engineering Contradiction:
Improvedetection sensitivity in vaccinated individualsVSAvoidapplicability to vaccinated populations
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The invention designs oligomers with specific local qualities - each oligomer is tailored to recognize specific HPV type sequences that may differ in vaccinated individuals. This local optimization of oligomer sequences enables sensitive detection even when viral load is reduced by vaccination, maintaining adaptability to vaccinated populations

Inventive Principle:
Principle #3Local quality

3Loss of information

If multiple HPV types are detected simultaneously, then comprehensive diagnostic information is provided, but assay complexity increases

Engineering Contradiction:
Improvecomprehensive diagnostic informationVSAvoidassay complexity
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The invention merges multiple detection capabilities into a single assay system by combining multiple specific oligomers (targeting different HPV types) with universal amplification and detection components. This merging provides comprehensive diagnostic information for multiple high-risk HPV types while managing complexity through a unified assay platform rather than separate tests for each type

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

These assays provide sensitive and efficient detection of HPV nucleic acid sequences, enabling effective diagnostic and prognostic information for HPV infections, monitoring of cancer risk, and assessment of vaccination efficacy, with the ability to detect as few as 25-200 copies of target RNA in a sample.

Implementation Method 1

The method includes the steps of amplifying at least one HPV nucleic acid sequence of an E6/E7 target region by using a mixture of amplification oligomers to produce an amplified HPV product

Methodology Applied
Scientific EffectNucleic acid hybridization:

Implementation Method 2

amplifying at least one HPV nucleic acid sequence of an E6/E7 target region by using a mixture of amplification oligomers in vitro to produce an amplified HPV product

Methodology Applied
Scientific EffectIn vitro nucleic acid amplification:

Implementation Method 3

detecting the amplified product by using a detection probe that is sufficiently complementary to hybridize specifically with the amplified HPV product

Methodology Applied
Scientific EffectNucleic acid hybridization:

Data Source

PatentUS10465255B2Detection of nucleic acids from multiple types of human papillomavirus
Publication Date: 2019.11.05 GEN PROBE INC
  • US10465255B2 patent drawing

AI summary

Nucleic acid oligonucleotide sequences are disclosed which include amplification oligomers and probe oligomers which are useful for detecting multiple types of human papillomaviruses (HPV) associated with cervical cancer. Methods for detecting multiple HPV types in biological specimens by amplifying HPV nucleic acid sequences in vitro and detecting the amplified products are disclosed.