Saliva Sampling Matrix With Pathogen Inactivation at Ambient Transport

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Solution Overview

Problem

Current biological test sampling methods are invasive, resource-intensive, and require cold chain storage, posing risks of pathogen transmission and limiting access to high-quality samples for accurate testing, especially for conditions like Alzheimer's disease and COVID-19, which necessitate non-invasive, safe, and reliable sample collection methods for self-administration and ambient transport.

Innovation Solution

A biological test sampling device with a solid matrix incorporating an inactivating solution that includes detergents, chaotropic salts, weak bases, chelators, and reducing agents to inactivate pathogens while preserving analytes like nucleic acids and proteins, allowing for subsequent analysis without cold chain storage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If nasopharyngeal swabs are used for respiratory virus diagnostics, then pathogen detection accuracy is improved, but patient comfort deteriorates and healthcare worker safety is compromised

Engineering Contradiction:

Improvepathogen detection accuracyVSAvoidpatient discomfort and healthcare worker exposure risk

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces saliva as an intermediary medium between the respiratory tract and the testing process. Instead of directly contacting the respiratory tract with invasive swabs, the device collects saliva which contains respiratory pathogens, thereby maintaining detection accuracy while eliminating patient discomfort and healthcare worker exposure risks

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical nasopharyngeal swabbing procedure with a chemical/inactivating solution-based system. The inactivating solution in the collection device chemically inactivates pathogens during collection, substituting the mechanical invasion and manual handling processes with a automated chemical inactivation mechanism

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If cold chain storage is used for sample transport, then sample quality is maintained, but testing cost increases and accessibility is limited

Engineering Contradiction:

Improvesample qualityVSAvoidtesting cost and accessibility

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent applies preliminary inactivation action during the sample collection phase using an inactivating solution containing chaotropic salts and detergents. This preliminary action stabilizes the sample immediately at the point of collection, eliminating the need for subsequent cold chain storage and transport infrastructure

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent changes the sample preservation parameter from temperature-based (cold chain at 2-8°C) to chemical-based (inactivating solution with chaotropic salts and detergents). This parameter change allows samples to be stored and transported at ambient temperatures while maintaining quality and stability

Inventive Principle:

Principle #35Parameter changes

3Measurement precision

If invasive sampling methods are used, then diagnostic accuracy is improved, but patient compliance for repeat testing deteriorates

Engineering Contradiction:

Improvediagnostic accuracyVSAvoidpatient compliance for repeat testing

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The patent uses saliva as an intermediary that provides non-invasive sampling while maintaining diagnostic accuracy. Saliva collection is as accurate as invasive methods for detecting respiratory pathogens but is vastly more comfortable for patients, enabling repeat testing and improving compliance

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent enables self-collection of saliva samples by patients in their own homes or workplaces, eliminating the need for healthcare worker involvement in the invasive nasopharyngeal swabbing process. This self-service approach dramatically improves patient compliance for repeat testing

Inventive Principle:

Principle #25Self-service

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 device effectively inactivates pathogens in biofluid samples within minutes, ensuring safe handling and transport at ambient temperatures, facilitating high-quality laboratory testing and enabling early detection of diseases like Alzheimer's and COVID-19 through non-invasive saliva sampling.

Implementation Method 1

the inactivating solution comprises a combination of protein denaturants selected from one or more detergents, one or more chaotropic salts, one or more weak bases, one or more chelators and one or more reducing agents

Methodology Applied

Scientific EffectProtein denaturation:

Implementation Method 2

one or more chaotropic salts

Methodology Applied

Scientific EffectChaotropic salt action:

Data Source

PatentUS20260035756A1Biological test sampling kit

Publication Date: 2026.02.05 HEMODX AS

AI summary

The present invention relates to methods and kits for the collection, preservation and storage of analytes of interest present in biological test samples (biofluid samples). In particular, the present invention relates to means to collect the biological test sample such that substantially all pathogen present in the biological test sample is inactivated, while preserving the analyte of interest in a format to allow subsequent analysis.