Multiplex PCR and Pooled Susceptibility Testing for Polymicrobial UTI Diagnosis

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Solution Overview

Problem

Current diagnostic methods for urinary tract infections (UTIs), such as standard urine culture (SUC), are limited by slow results, poor detection of polymicrobial infections, and inability to assess pooled antibiotic susceptibility, leading to inadequate treatment and increased antibiotic resistance.

Innovation Solution

A novel diagnostic assay combining multiplex polymerase chain reaction (M-PCR) with pooled antibiotic susceptibility testing (P-AST) provides rapid identification of bacteria and antibiotic resistance genes, allowing for phenotypic antibiotic susceptibility testing using fluorescent probes like resazurin, which assesses metabolic activity to determine viable bacterial growth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If standard urine culture (SUC) is used for UTI diagnosis, then organism identification can be achieved, but the diagnostic time is extended (3-5 days) and polymicrobial detection is poor

Engineering Contradiction:
Improveorganism identification accuracyVSAvoiddiagnostic time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent combines multiplex PCR (M-PCR) technology with pooled antibiotic susceptibility testing (P-AST) to simultaneously achieve rapid pathogen identification and antibiotic susceptibility assessment. M-PCR enables detection of multiple bacterial pathogens and resistance genes in a single reaction, while P-AST evaluates pooled bacterial susceptibility to multiple antibiotics, resolving the contradiction between diagnostic speed and comprehensiveness.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The diagnostic system performs multiple functions simultaneously: it identifies bacterial pathogens, detects antibiotic resistance genes, and assesses phenotypic antibiotic susceptibility. This multi-functional approach eliminates the need for separate testing procedures, thereby reducing diagnostic time while maintaining comprehensive organism identification accuracy.

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

2Measurement precision

If standard urine culture (SUC) is used, then organism identification is performed, but pooled antibiotic susceptibility cannot be assessed

Engineering Contradiction:
Improveorganism identificationVSAvoidantibiotic susceptibility information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The patent merges organism identification and antibiotic susceptibility assessment into a single integrated diagnostic workflow. M-PCR identifies pathogens and resistance genes, while P-AST simultaneously evaluates antibiotic susceptibility of the pooled bacterial population, ensuring both identification accuracy and susceptibility information are obtained together.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system performs preliminary pooled antibiotic susceptibility testing before individual pathogen isolation. By testing antibiotics against pooled bacteria containing all detected pathogens, the system obtains preliminary susceptibility information that guides subsequent targeted therapy, preventing loss of critical antibiotic effectiveness data.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If empirical therapy is used due to inadequate diagnostic information, then treatment can be initiated quickly, but treatment failures and antibiotic resistance increase

Engineering Contradiction:
Improvetreatment initiation speedVSAvoidtreatment success rate
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The diagnostic system performs preliminary pathogen identification and antibiotic susceptibility assessment before treatment initiation. By providing preliminary diagnostic information including which antibiotics are likely to be effective, the system enables clinicians to start targeted therapy immediately, avoiding both delays and empirical treatment failures.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system provides feedback on antibiotic susceptibility results that directly inform treatment decisions. By returning information about which antibiotics effectively inhibit the detected pathogens, the system creates a feedback loop that improves treatment selection accuracy and reduces both treatment failures and antibiotic resistance development.

Inventive Principle:
Principle #23Feedback

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 combination significantly reduces treatment failures and antibiotic resistance by providing accurate, rapid detection of UTI-causing pathogens and their susceptibility to antibiotics, leading to improved patient outcomes and reduced empirical therapy use.

Implementation Method 1

multiplex polymerase chain reaction (M-PCR) provides rapid identification of bacteria and antibiotic resistance genes

Methodology Applied
Scientific EffectPolymerase chain reaction (PCR):

Implementation Method 2

phenotypic antibiotic susceptibility testing using fluorescent probes like resazurin, which assesses metabolic activity to determine viable bacterial growth

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS20240401104A1Methods and systems for determining suitability of compositions for inhibiting growth of polymicrobial samples
Publication Date: 2024.12.05 CAP DIAGNOSTICS LLC
  • US20240401104A1 patent drawing
  • US20240401104A1 patent drawing
  • US20240401104A1 patent drawing

AI summary

Methods for identifying and providing information about inhibiting growth of polymicrobial infections, including but not limited to providing statistics or information about the likelihood of success in inhibiting growth of a polymicrobial infection with particular compositions or therapeutic solutions. The methods herein feature detection and identification of organisms of the polymicrobial sample (e.g., polymicrobial infection), phenotypic pooled sensitivity tests for determining the susceptibility or resistance of the polymicrobial sample (e.g., polymicrobial infection) in the sample to an antibiotic or other therapeutic agent, and identification of resistance genes, e.g., genetic markers that may indicate resistance to a particular treatment. Together, the data can be applied against databases of antibiotic/therapeutic susceptibility or resistance for particular known polymicrobial samples (e.g., polymicrobial infections) in order to provide information related to the likelihood of success of one or more therapeutic solutions for the polymicrobial sample (e.g., polymicrobial infection).