Real-time PCR Detection of Trichomonas vaginalis

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Solution Overview

Problem

Current methods for detecting Trichomonas vaginalis, such as culture and microscopic examination, are not sufficiently sensitive and reliable, particularly for asymptomatic cases, leading to challenges in early detection and prevention of associated complications like HIV acquisition and adverse pregnancy outcomes.

Innovation Solution

A real-time polymerase chain reaction (PCR) method using specific primers and probes targeting the 5.8s ribosomal RNA gene of Trichomonas vaginalis, allowing for rapid and accurate detection in a single test tube, with the potential to differentiate it from closely related species like Trichomonas tenax and Pentatrichomonas hominis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If culture method is used for detection, then reliability is improved, but sensitivity deteriorates (38-82% sensitivity compared to molecular methods)

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoiddetection sensitivity
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent replaces the mechanical/cultural system of traditional culture methods with a molecular amplification system (PCR). By using nucleic acid amplification technology, the method achieves both high sensitivity (comparable to or exceeding molecular methods) and high reliability (specific detection of T. vaginalis), resolving the contradiction between reliability and sensitivity that plagues traditional culture methods.

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

2Ease of operation

If wet-mount microscopic examination is used, then ease of operation is improved, but sensitivity deteriorates (35-80% sensitivity compared with culture)

Engineering Contradiction:
Improveconvenience of detectionVSAvoiddetection sensitivity
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent replaces the optical/mechanical system of microscopic examination with a molecular amplification and detection system. The real-time PCR method maintains ease of operation through automated cycling and fluorescent detection, while dramatically improving sensitivity by amplifying specific nucleic acid sequences, thus resolving the contradiction between ease of operation and sensitivity.

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

3Ease of operation

If wet-mount method is used, then ease of operation is improved, but reliability deteriorates due to dependency on microscopist experience and specimen transport time

Engineering Contradiction:
Improveconvenience of detectionVSAvoidconsistency of detection
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent replaces the human-dependent optical examination system with an automated molecular amplification and fluorescent detection system. The real-time PCR process is standardized and automated, eliminating variability due to microscopist experience and specimen transport time, thereby improving reliability while maintaining ease of operation through a straightforward protocol.

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

4Measurement precision

If real-time PCR method is used, then sensitivity is improved, but device complexity increases

Engineering Contradiction:
Improvedetection sensitivityVSAvoidcomplexity of detection system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple functions into a single real-time PCR system: nucleic acid amplification, fluorescent probe hybridization, and signal detection all occur in the same reaction tube without requiring separate steps for each function. This integration reduces the overall complexity of the detection system while maintaining high sensitivity, as the amplification and detection processes are merged into one automated workflow.

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

This method provides enhanced sensitivity and specificity for detecting Trichomonas vaginalis, enabling early identification and potentially reducing the transmission of associated infections, including HIV, and improving pregnancy outcomes by facilitating timely intervention.

Implementation Method 1

performing an amplifying step including contacting the sample with a set of primers designed to target a specific TV gene to produce an amplification product if TV is present in the sample

Methodology Applied
Scientific EffectPolymerase chain reaction (PCR):

Implementation Method 2

performing a hybridizing step including contacting the amplification product with one or more detectable probes to the target TV gene

Methodology Applied
Scientific EffectHybridization:

Data Source

PatentEP3464617B1Compositions and methods for detection of trichomonas vaginalis
Publication Date: 2021.04.07 ROCHE DIAGNOSTICS GMBH
  • EP3464617B1 patent drawingFigure 1
  • EP3464617B1 patent drawingFigure 2
  • EP3464617B1 patent drawingFigure 3

AI summary

Methods for the rapid detection of the presence or absence of Trichomonas vaginalis (TV) in a biological or non-biological sample are described. The methods can include performing an amplifying step, a hybridizing step, and a detecting step. Furthermore, primers, probes targeting the target TV gene, along with kits are provided that are designed for the detection of TV.