HPV Biomarker Detection via Mass Spectrometry

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Solution Overview

Problem

Current HPV diagnosis methods are inadequate due to high false negatives, high costs, sampling difficulties, contamination issues, and inability to detect multiple biomarkers in a single test, leading to inefficient and potentially unnecessary medical procedures.

Innovation Solution

A method using mass spectrometry to generate mass profile data from biological samples, correlating it with reference profiles to detect the presence or absence, and quantify biomarkers associated with HPV, allowing for a single test to identify multiple biomarkers and differentiate between their forms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current HPV diagnosis methods (Pap smear, Hybrid capture, PCR) are used, then HPV infection can be detected, but false negatives occur frequently and sensitivity is insufficient

Engineering Contradiction:
Improvedetection sensitivityVSAvoidfalse negative rate
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The invention segments the detection process into multiple independent biomarker targets (E6, E7, p16, p53) rather than relying on a single test. Each biomarker is detected separately through mass spectrometry, allowing comprehensive coverage of different HPV infection stages and reducing false negatives that occur when any single marker is missed.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mass spectrometry platform serves multiple detection functions simultaneously - it can identify various HPV biomarkers (E6, E7, p16, p53) in a single test, providing universal detection capability across different HPV strains and infection stages, thereby improving overall detection sensitivity and reliability.

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

2Measurement precision

If multiple separate tests are performed to detect different HPV biomarkers, then comprehensive detection is achieved, but testing complexity and cost increase

Engineering Contradiction:
Improvecomprehensive biomarker detectionVSAvoidnumber of tests required
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention merges the detection of multiple HPV biomarkers (E6, E7, p16, p53) into a single mass spectrometry test. The mass spectrometry instrument simultaneously analyzes all biomarkers in one run, eliminating the need for multiple separate tests and reducing overall testing complexity while maintaining comprehensive detection capability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The mass spectrometry platform provides multi-functional detection capability, serving as a universal instrument that can identify all HPV-related biomarkers through a single analytical process. This consolidates what would traditionally require multiple specialized tests into one versatile platform.

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

3Measurement precision

If traditional immunoassays are used to detect HPV proteins, then biomarker presence can be determined, but the ability to distinguish between different forms of biomarkers is limited

Engineering Contradiction:
Improvebiomarker identification accuracyVSAvoiddifferentiation of biomarker forms
Core Design Contradiction:
Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

The mass spectrometry detection method provides distinct mass-to-charge ratio signals for different biomarker forms, analogous to color changes in visual detection. Each biomarker variant produces a unique spectral signature that can be clearly distinguished and identified, enabling precise differentiation between various forms of HPV-associated proteins.

Inventive Principle:
Principle #32Color changes

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 provides higher sensitivity and specificity, reduces false-positive rates, and enables early and accurate diagnosis of HPV infections, potentially preventing the progression to cervical cancer by identifying oncogenic strains and their severity.

Implementation Method 1

generating mass profile data (e.g., mass spectrum) for a biological sample of a given subject

Methodology Applied
Scientific EffectMass spectrometry:

Data Source

PatentUS7776522B2Methods for diagnosing oncogenic human papillomavirus (HPV)
Publication Date: 2010.08.17 BECTON DICKINSON & CO
  • US7776522B2 patent drawing
  • US7776522B2 patent drawing

AI summary

Methods for diagnosis of HPV infection in a subject are provided. HPV infection in a subject can be determined by generating mass profile data for a biological sample from the subject and correlating the mass profile data with reference mass profiles to detect the presence or absence, and/or quantity of at least one biomarker associated with HPV infection. Methods for detecting at least one biomarker associated with HPV infection in a biological sample are also provided.