Filter Column Nucleic Acid Stabilization for Ambient Shipping

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Solution Overview

Problem

Current systems for collecting and processing nucleic acids from biological samples are complex, require multiple steps, and are not optimized for large volumes or prevention of cross-contamination, especially in resource-limited settings, making it challenging to detect altered nucleic acids at low concentrations for clinical diagnostics.

Innovation Solution

A system comprising a receptacle with a removable cap, a filter column with a binding matrix, and a shipping container with desiccant, allowing for efficient lysing, binding, washing, and stabilization of nucleic acids, enabling collection and shipment of samples from minimally-equipped medical settings for further analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current extraction methods are used, then nucleic acids can be extracted from biological samples, but the process becomes complex and requires multiple steps with technically trained personnel

Engineering Contradiction:
Improvenucleic acid extraction reliabilityVSAvoidextraction process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple extraction steps (lysing, binding, washing, eluting) into a single integrated filter column device. The filter column contains all necessary functional zones within one structure, allowing nucleic acid extraction to be performed in a single operation rather than requiring multiple separate steps and containers.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The filter column serves multiple functions simultaneously: it acts as a lysis container, binding column, washing column, and elution device. The single device performs what previously required multiple specialized tools and trained personnel operations, making the extraction process universal and accessible.

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

2Quantity of substance

If large volumes of biological fluid are processed, then sufficient nucleic acids can be collected, but cross-contamination and environmental contamination risk increases

Engineering Contradiction:
Improvenucleic acid quantityVSAvoidcontamination risk
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The filter column extracts and binds nucleic acids from large volumes of biological fluid directly within the closed column structure. By confining the extraction process within the sealed filter column, the system prevents environmental contamination while still processing large sample volumes to obtain sufficient nucleic acid quantity.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The filter column acts as an intermediary containment structure between the large volume biological sample and the external environment. It mediates the extraction process by allowing nucleic acids to be bound and concentrated within its closed structure, preventing cross-contamination while enabling large volume processing.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If nucleic acids are collected at point of care facilities, then analysis can be performed locally, but sample stabilization for shipment becomes challenging

Engineering Contradiction:
Improvepoint of care accessibilityVSAvoidnucleic acid stability during shipment
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The filter column performs preliminary stabilization of nucleic acids during the extraction process itself. By binding nucleic acids to the filter matrix and completing the extraction in a controlled environment, the system prepares and stabilizes the sample for subsequent shipment, eliminating the need for separate stabilization steps.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system merges the extraction function with the stabilization function into a single filter column operation. The same device that extracts nucleic acids also stabilizes them through its closed structure and binding mechanism, making the sample ready for shipment immediately after use.

Inventive Principle:
Principle #5Merging (Combining)

4Measurement precision

If expensive processing equipment is used for nucleic acid analysis, then detection sensitivity improves, but accessibility in resource-limited settings decreases

Engineering Contradiction:
Improvenucleic acid detection sensitivityVSAvoidsystem accessibility
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The filter column is designed as a disposable, low-cost device that can be manufactured inexpensively and used once, then discarded. This eliminates the need for expensive, maintainable processing equipment while still providing reliable nucleic acid extraction and stabilization, making the system accessible to resource-limited settings.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The system extracts and stabilizes nucleic acids in a simple, low-cost filter column that can be manufactured affordably. By performing the extraction and stabilization functions in this inexpensive device rather than requiring complex equipment, the system maintains detection sensitivity while dramatically improving accessibility to resource-limited areas.

Inventive Principle:
Principle #2Taking out (Extraction)

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

The system effectively collects and stabilizes nucleic acids from large volumes, preventing contamination and degradation, allowing for reliable detection of low-concentration nucleic acids, such as those indicative of tuberculosis, even in resource-limited environments, with samples remaining stable for up to 4 weeks under ambient conditions.

Implementation Method 1

a filter column having an open first end, an open second end, and an internal passage therebetween containing a substrate for collecting the nucleic acid

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

The shipping container further comprises a removable lid for temporarily sealing the filter column within the shipping container. The shipping container contains a desiccant in some embodiments.

Methodology Applied
Scientific EffectDesiccation: Desiccation

Data Source

PatentEP3003561B1System and method for collecting a sample of nucleic acid
Publication Date: 2018.12.19 OCCAM BIOLABS
  • EP3003561B1 patent drawingFigure 1A
  • EP3003561B1 patent drawingFigure 1B
  • EP3003561B1 patent drawingFigure 1C

AI summary

A system for collecting and shipping a sample of nucleic acid, the system comprising a receptacle, a removable cap for the receptacle having a breather port and sample connection port, and a filter column removably attached to the inside of the receptacle cap in fluid communication with the sample connection port and containing a substrate for collecting the nucleic acid. A sample collection container interlocks to the sample collection port. A shipping container, closeable by a lid, is configured to detach the filter column from the receptacle cap and contain the column for shipping. Methods for collecting samples using the system preferably include a dehydrating wash step, such as with ethanol, and placement of a dessicant in the shipping container, so that nucleic acid samples can be transported under ambient, non-climate-controlled conditions, with stability for at least up to 4 weeks, ideal for collecting samples from undeveloped regions.