NGU and HIV Detection Kits Using PCR Probe Hybridization

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current methods are inadequate for accurately diagnosing and treating nongonococcal urethritis (NGU) and assessing the risk of human immunodeficiency virus (HIV) infections based on the genitourinary microbiome, as the relationships between bacterial species and these conditions are not well understood.

Innovation Solution

The development of kits and methods that detect and classify NGU and HIV infections by identifying specific pathogens in urethral and vaginal samples using PCR and probe hybridization techniques, allowing for targeted therapeutic interventions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If PCR and probe hybridization techniques are used to detect specific pathogens, then measurement precision of pathogen detection is improved, but device complexity increases

Engineering Contradiction:
Improvepathogen detection accuracyVSAvoiddetection system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The detection system is segmented into distinct functional modules: PCR amplification module with specific primers for target pathogens, probe hybridization module with fluorescently labeled probes, and detection module. Each module performs a specific function, allowing for optimized performance while managing complexity through modular design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Fluorescently labeled probes serve as intermediaries between the amplified pathogen DNA and the detection system. The probes specifically bind to target sequences and emit fluorescent signals that can be detected, thereby translating molecular recognition into measurable signals with high precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If multiple pathogens are detected simultaneously, then adaptability of the diagnostic system is improved, but manufacturing precision requirements increase

Engineering Contradiction:
Improvemulti-pathogen detection capabilityVSAvoidprimer and probe specificity
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The diagnostic kit is designed with universal functionality to detect multiple pathogens including N. gonorrhoeae, C. trachomatis, M. genitalium, and other urogenital pathogens simultaneously. The system uses a panel of pathogen-specific primers and probes that can be applied in a single PCR reaction, enabling multi-pathogen detection with a unified platform.

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

Solution Approach 2:

Each primer and probe in the multiplex system is designed with high local specificity to its target pathogen sequence. The primers and probes have optimized binding characteristics for their respective targets, allowing specific amplification and detection of each pathogen even in the presence of multiple pathogens and complex sample matrices.

Inventive Principle:
Principle #3Local quality

3Reliability

If comprehensive microbiome analysis is performed, then reliability of infection risk assessment is improved, but loss of time in processing increases

Engineering Contradiction:
Improveinfection risk assessment accuracyVSAvoiddiagnostic processing time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary amplification of pathogen-specific DNA sequences using PCR before detection. This preliminary action concentrates and enriches the target analytes from complex microbiome samples, enabling reliable detection of low-abundance pathogens and improving the reliability of infection risk assessment while managing processing time through efficient amplification protocols.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system replaces traditional culture-based methods and manual examination with automated PCR amplification and fluorescent probe detection. This substitution of mechanical and manual processes with automated molecular biology techniques reduces processing time while maintaining or improving the reliability of infection risk assessment through objective, quantifiable results.

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

Enables effective detection, classification, and treatment of NGU and HIV infections by identifying Haemophilus influenzae, Mycoplasma penetrans, and other pathogens, thereby improving patient prognosis and preventing infection.

Implementation Method 1

a first primer set that hybridizes to first nucleotide sequences of Haemophilus influenzae or Mycoplasma penetrans to generate a Haemophilus influenzae or Mycoplasma penetrans specific amplicon

Methodology Applied
Scientific EffectHybridization:

Implementation Method 2

hybridizes to first nucleotide sequences... to generate a... specific amplicon

Methodology Applied
Scientific EffectPCR amplification:

Implementation Method 3

a first probe capable of hybridizing to the Haemophilus influenzae or Mycoplasma penetrans specific amplicon

Methodology Applied
Scientific EffectHybridization:

Data Source

PatentUS11884984B2Kits and methods for assessing a condition or a risk of developing a condition, and related methods of treatment
Publication Date: 2024.01.30 FRED HUTCHINSON CANCER RESEARCH CENTER
  • US11884984B2 patent drawing
  • US11884984B2 patent drawing
  • US11884984B2 patent drawing

AI summary

Provided herein are kits and methods for detecting, monitoring, and classifying a nongonococcal urethritis (NGU) infection in a male subject based on a genitourinary microbiome of a subject, as well as related methods of treating.Also provided are kits and methods for classifying a risk of human immunodeficiency virus (HIV) infection in a subject based on a genitourinary microbiome of a subject, as well as related methods of preventing infection.