Selective Nucleic Acid Separation via Aqueous Lysis and Filtration

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Solution Overview

Problem

Current methods for enriching nucleic acids from rare cells are hindered by low purity and high contamination from non-disease-associated nucleic acids, leading to insensitive and prone-to-false-results analysis, and fixation processes further complicate RNA integrity and recovery.

Innovation Solution

A method involving an aqueous medium that selectively releases nucleic acids from non-rare cells while preserving those from rare cells, followed by filtration to separate and concentrate intact nucleic acids from rare cells, using a porous matrix to retain rare cells and allow non-rare cells and released nucleic acids to pass through.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If cell filtration is performed without fixation to preserve nucleic acid integrity, then RNA quality is improved, but recovery of diseased cells decreases to less than 40%

Engineering Contradiction:
Improvenucleic acid integrityVSAvoidrecovery of diseased cells
Core Design Contradiction:
Stability of the object's compositionVSProductivity

Solution Approach 1:

The patent applies preliminary action by performing fixation after filtration rather than before. The method first separates cells through filtration while they are intact and viable, then applies fixation to the collected rare cells. This sequence preserves nucleic acid integrity during the critical separation phase while still achieving high recovery rates through subsequent fixation of the concentrated rare cell population.

Inventive Principle:
Principle #10Preliminary action

2Productivity

If fixation is applied to increase recovery of diseased cells to greater than 90%, then productivity is improved, but nucleic acids become heavily fragmented and chemically modified

Engineering Contradiction:
Improverecovery of diseased cellsVSAvoidnucleic acid integrity
Core Design Contradiction:
ProductivityVSStability of the object's composition

Solution Approach 1:

The patent reverses the conventional sequence by performing filtration before fixation. Rare cells are first isolated through filtration while maintaining their natural state, ensuring nucleic acids remain intact. Only after the rare cells are collected and concentrated does the method apply fixation, thereby achieving high recovery rates without compromising nucleic acid quality for downstream applications.

Inventive Principle:
Principle #10Preliminary action

3Quantity of substance

If nucleic acids are concentrated from samples with few rare cells, then the amount of nucleic acids is increased, but purity decreases due to contamination from non-disease-associated nucleic acids

Engineering Contradiction:
Improveamount of nucleic acidsVSAvoidpurity of nucleic acids
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The patent applies segmentation by separating the enrichment process into two distinct stages: first, physical separation of rare cells from the bulk sample through filtration; second, concentration of nucleic acids from the isolated rare cells. This segmentation ensures that nucleic acids are concentrated only from the purified rare cell population, excluding non-disease-associated nucleic acids from non-rare cells, thereby achieving both high concentration and high purity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The method performs preliminary cell separation before nucleic acid concentration. By first filtering to isolate rare cells and remove the majority of non-rare cells, the subsequent nucleic acid extraction and concentration steps operate on a pre-purified cell population. This preliminary action prevents contamination from non-disease-associated nucleic acids while still achieving sufficient nucleic acid concentration for detection.

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

This approach enhances the recovery and purity of disease-associated nucleic acids, enabling sensitive and accurate determination of rare cell nucleic acids, even at low concentrations, and maintains RNA integrity for downstream applications.

Implementation Method 1

The combination is held for a period of time and at a temperature for selectively releasing nucleic acids from the non-rare cells but not from the rare cells

Methodology Applied
Scientific EffectSelective lysis:

Implementation Method 2

The sample is subjected to filtration to separate rare cells from non-rare cells

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Data Source

PatentEP3164204B1Selective nucleic acid separation
Publication Date: 2021.03.10 SIEMENS HEALTHCARE DIAGNOSTICS INC

AI summary

Nucleic acids in non-rare cells in a sample containing non-rare cells and rare cells are selectively released from the non-rare cells. The sample is combined with an aqueous medium, and the combination is held for a period of time and at a temperature for selectively releasing nucleic acids from the non-rare cells but not from the rare cells. The sample is subjected to filtration to separate rare cells from non-rare cells. Rare cells with intact nucleic acids are separated from non-rare cells and nucleic acids from the non-rare cells. Nucleic acids from the rare cells are subjected to one or more identification techniques either with or without extraction of nucleic acids from the rare cells.