Single-Cell Digital HRM for Accurate Microbial Cell Counting

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Solution Overview

Problem

Existing methods for microbial detection, such as digital High Resolution Melting (dHRM) and digital PCR, struggle with accurate quantification and linkage of antibiotic resistances due to DNA extraction biases, species-specific differences, and contamination by non-microbial DNA, leading to inaccurate cell counts and loss of linkage information.

Innovation Solution

A method involving selective enrichment of microbial cells, partitioning them into fixed reaction chambers for in situ lysis and amplification, followed by digital High Resolution Melting (dHRM) analysis, which allows for simultaneous identification and quantification of microbial cells and their genetic markers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of information

If DNA extraction is performed in bulk, then amplification can be carried out, but linkage information between genetic markers is lost due to fragmentation and separation

Engineering Contradiction:
Improvelinkage informationVSAvoidDNA extraction process
Core Design Contradiction:
Loss of informationVSEase of manufacture

Solution Approach 1:

The patent divides the sample into individual reaction chambers (partitioning) before lysis, so that each chamber contains material from a single cell or organism. This segmentation prevents the mixing and fragmentation that occurs in bulk extraction, thereby preserving linkage information between genetic markers within each partition.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent performs partitioning of the sample into individual reaction chambers before carrying out lysis and DNA extraction. This preliminary action ensures that linkage information is preserved from the outset, as the physical separation occurs prior to any fragmentation that would occur during subsequent processing steps.

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If conventional PCR-based methods are used, then amplification of target DNA can be achieved, but accurate cell counts cannot be obtained due to genetic ploidy differences and DNA extraction biases

Engineering Contradiction:
Improvecell count accuracyVSAvoidmethodology limitations
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

By partitioning the sample into many individual reaction chambers, the patent enables digital counting of amplification events. Each positive reaction chamber represents a single starting template (cell), allowing for accurate cell count measurement that is independent of genetic ploidy differences and DNA extraction efficiencies.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent replaces the mechanical/biochemical process of quantifying DNA amount (which is affected by ploidy and extraction bias) with a digital counting approach based on partitioned amplification events. This substitution of measurement methodology eliminates the sources of bias inherent in conventional PCR-based quantification.

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

3Measurement precision

If non-microbial DNA is present in the sample, then DNA extraction can be performed, but detection accuracy decreases due to inhibition and background noise

Engineering Contradiction:
Improvedetection accuracyVSAvoidnon-microbial DNA
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent selectively removes or enriches for microbial cells before partitioning and lysis. By taking out the non-microbial DNA through selective enrichment steps prior to the partitioning process, the background noise and inhibition are reduced, thereby improving detection accuracy of the target microbial sequences.

Inventive Principle:
Principle #2Taking out (Extraction)

4Measurement precision

If digital PCR with TaqMan probes is used, then specific detection can be achieved, but quantitative information about mixed samples is lost

Engineering Contradiction:
Improvespecific detectionVSAvoidquantitative information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The patent uses a universal amplification approach that can detect and quantify multiple different targets in the same reaction chamber. By combining partitioning with universal amplification and melt curve analysis, the system achieves both specific detection of individual targets and quantitative information about mixed samples, eliminating the trade-off present in TaqMan probe-based digital PCR.

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

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 accurate cell counts and linkage of genetic markers, reducing biases from DNA extraction and enabling precise treatment strategies for multi-resistant organisms by maintaining linkage information within the same reaction chamber.

Implementation Method 1

The HRM process in its simplest form entails a melting step during which precise control of a heating element allows for the sequence-dependent denaturation of double-stranded DNA (dsDNA) to single stranded DNA (ssDNA)

Methodology Applied
Scientific EffectThermal denaturation: Melting

Implementation Method 2

lysis of the microscopic organism to release nucleic acid

Methodology Applied
Scientific EffectCell lysis: Decomposition (biological)

Data Source

PatentEP3999624B1Methods and devices for single-cell based digital high resolution melt
Publication Date: 2026.03.25 MELIOLABS INC
  • EP3999624B1 patent drawingFigure 1
  • EP3999624B1 patent drawingFigure 2
  • EP3999624B1 patent drawingFigure 3

AI summary

Provided are devices, systems, and methods for the identification, quantification, and profiling of microscopic organisms. The methods for the identification, quantification, and profiling of microscopic organisms include, for example, the selective enrichment of microscopic organisms from a heterogeneous sample; subsequent loading of the microscopic organisms into microfluidic channels or reaction chambers; direct amplification of nucleic acids from single, isolated microscopic organisms; and examination of amplification products using digital High Resolution Melting (HRM) analysis.