Gardnerella vaginalis Nucleic Acid Detection via Strand Displacement

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Solution Overview

Problem

Current methods for detecting Gardnerella vaginalis often result in false negative outcomes due to difficulties in isolating toxins produced by the organism, rather than detecting the organism itself, leading to a need for an assay that can accurately identify the presence of GV without relying on toxin detection.

Innovation Solution

The development of oligonucleotide-based methods using strand displacement amplification (SDA) or PCR assays that target highly conserved regions of the vly gene in Gardnerella vaginalis, allowing for the direct detection and quantitation of the organism, with the use of internal amplification controls to minimize false negatives.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If toxin detection methods are used to detect Gardnerella vaginalis, then the detection can be performed, but false negative results occur due to difficulties in isolating toxins

Engineering Contradiction:
Improvedetection accuracyVSAvoidtoxin isolation difficulty
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent extracts the detection target from toxins to the organism's nucleic acid itself. Instead of detecting extracellular toxins produced by GV, the assay directly detects GV nucleic acid sequences, eliminating the isolation difficulties associated with toxin detection while maintaining detection capability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces nucleic acid amplification technology as an intermediary mechanism. By using PCR or SDA to amplify GV-specific nucleic acid sequences before detection, the assay overcomes the low abundance and isolation difficulties of toxins, enabling reliable detection of the organism itself.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If direct organism detection methods are developed, then false negatives are reduced, but the assay complexity increases

Engineering Contradiction:
Improvefalse negative reductionVSAvoidassay complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the detection parameter from toxin presence to nucleic acid sequence presence. By targeting highly conserved regions of the vly gene, the assay achieves reliable organism detection while using standardized molecular biology techniques (PCR/SDA) that are well-established and do not require complex new equipment.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent incorporates preliminary nucleic acid amplification steps before detection. By pre-amplifying the target nucleic acid sequences using PCR or SDA, the assay ensures sufficient signal for detection while using routine laboratory techniques, balancing reliability improvement with acceptable procedural complexity.

Inventive Principle:
Principle #10Preliminary action

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

These methods provide a sensitive and specific means to detect Gardnerella vaginalis, reducing the occurrence of false negatives and allowing for the detection of the organism itself, rather than its toxins, thereby improving diagnostic accuracy.

Implementation Method 1

The present invention provides oligonucleotides that are complementary or that anneal to nucleic acid sequences of Gardnerella vaginalis for the amplification and/or detection of the same

Methodology Applied
Scientific EffectNucleic acid hybridization:

Implementation Method 2

amplifying the target sequence using a first amplification primer

Methodology Applied
Scientific EffectDNA polymerization:

Implementation Method 3

The present invention provides a strand displacement amplification (SDA) assay or a PCR assay for the amplification and/or detection of Gardnerella vaginalis nucleic acid sequences

Methodology Applied
Scientific EffectThermal denaturation:

Data Source

PatentUS9976190B2Gardnerella vaginalis assay
Publication Date: 2018.05.22 BECTON DICKINSON & CO
  • US9976190B2 patent drawing
  • US9976190B2 patent drawing
  • US9976190B2 patent drawing

AI summary

The present invention relates to nucleic acid amplification assays for the detection of nucleic acid sequences of Gardnerella vaginalis. The present invention provides oligonucleotides that are complementary or that anneal to nucleic acid sequences of the vly gene of GV. The present invention also provides internal amplification controls (IACs) that can be used in nucleic acid amplification reactions.