RNA Probe HPV Detection Kit Reducing False Positives

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Solution Overview

Problem

Current HPV detection methods, particularly PCR-based methods, face challenges such as high false positive and false negative rates, competitive inhibition, and low sensitivity and specificity, making them unsuitable for accurate and efficient detection of high-risk HPV types, especially in clinical settings.

Innovation Solution

A kit and method utilizing RNA probes specific to high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, combined with a chemiluminescence immune technology, allowing for accurate typing and detection without the need for DNA amplification or specialized conditions, using RNA probes that target specific DNA sequences and antibodies that recognize DNA-RNA heterozygotes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If PCR-based methods are used for HPV detection, then detection capability is achieved, but false positive and false negative rates increase and reliability decreases

Engineering Contradiction:
Improvedetection reliabilityVSAvoidtyping precision
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent introduces RNA probes as an intermediary between the target HPV DNA and the detection system. The RNA probes hybridize with complementary DNA sequences to form DNA-RNA heterozygotes, which then serve as targets for antibody detection. This intermediary approach avoids the amplification steps in PCR that cause false positives and negatives, while maintaining high typing precision through specific RNA-DNA hybridization and antibody recognition.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If DNA amplification is performed to increase sensitivity, then detection sensitivity improves, but competitive inhibition occurs and measurement precision deteriorates

Engineering Contradiction:
Improvetyping precisionVSAvoiddetection sensitivity
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The patent replaces the mechanical amplification process of PCR with a direct hybridization-antibody detection system. Instead of using polymerase enzymes to amplify DNA mechanically, the method uses RNA probes that directly hybridize with target DNA sequences, and the resulting DNA-RNA heterozygotes are detected by specific antibodies. This substitution eliminates competitive inhibition while maintaining high sensitivity and typing precision.

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

3Measurement precision

If complex laboratory conditions and specialized equipment are used to improve detection accuracy, then measurement precision improves, but device complexity and ease of operation worsen

Engineering Contradiction:
Improvedetection precisionVSAvoidlaboratory condition complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs a self-service detection system where the RNA probes automatically hybridize with complementary HPV DNA sequences in the sample, forming DNA-RNA heterozygotes that are then detected by antibodies. This self-hybridization process eliminates the need for complex amplification protocols, specialized equipment, and stringent laboratory conditions, while maintaining high detection precision through the inherent specificity of nucleic acid hybridization and antibody-antigen recognition.

Inventive Principle:
Principle #25Self-service

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 solution provides high specificity and sensitivity for detecting and typing high-risk HPV types, reducing false positives and negatives, and simplifying the detection process, making it suitable for clinical applications while minimizing experimental pollution and the need for complex laboratory conditions.

Implementation Method 1

nucleic acid hybridization chemiluminescence immune technology

Methodology Applied
Scientific EffectNucleic acid hybridization: Chemical Bonding

Implementation Method 2

nucleic acid hybridization chemiluminescence immune technology

Methodology Applied
Scientific EffectChemiluminescence: Chemiluminescence

Data Source

PatentEP3187596B1Method for detecting and typing high-risk human papillomaviruses
Publication Date: 2020.07.15 HANGZHOU DALTON BIOSCI
  • EP3187596B1 patent drawingFigure 1

AI summary

The present invention relates to a method for detecting and typing high-risk human papillomavirus (HPV). A probe having a specific detection function for 14 types of high-risk HPV is disclosed, and a technology capable of detecting and typing high-risk HPV DNA is developed on the basis of a nucleic acid hybridization chemiluminescence immunoassay technology.