High Throughput Nucleic Acid Testing via Isothermal Amplification

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Solution Overview

Problem

Current nucleic acid testing (NAT) for blood and plasma screening is time-consuming and costly, creating a bottleneck in the screening process, especially during health emergencies, and requires complex workflows that include pooling and deconstruction, which can lead to errors and increased costs.

Innovation Solution

A method for rapid nucleic acid analysis that can detect multiple pathogens or infectious agents within 15 to 60 minutes, allowing for the release of donor blood or plasma for clinical use, using techniques such as isothermal nucleic acid amplification reactions and optical or digital detection, enabling high-throughput screening with results in 20 to 3.5 hours and up to 140 results per hour per square meter of automated system footprint.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional nucleic acid testing (NAT) is used for blood and plasma screening, then pathogen detection sensitivity is improved, but testing time and operational complexity increase significantly

Engineering Contradiction:

Improvepathogen detection sensitivityVSAvoidtesting time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The testing process is segmented into independent parallel channels, each capable of detecting specific pathogens. Samples are divided into multiple reaction channels that can be processed simultaneously, reducing overall testing time while maintaining detection sensitivity for each pathogen type.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Nucleic acid extraction and preparation steps are performed in advance before the actual amplification and detection. Sample preprocessing is completed upfront, allowing the main testing phase to proceed more quickly without compromising detection accuracy.

Inventive Principle:

Principle #10Preliminary action

2Measurement precision

If traditional nucleic acid testing (NAT) is used for blood and plasma screening, then pathogen detection sensitivity is improved, but device and operational complexity increase

Engineering Contradiction:

Improvepathogen detection sensitivityVSAvoidworkflow complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

Multiple detection functions are merged into a single integrated system. The device combines nucleic acid extraction, amplification, and detection capabilities in one platform, reducing the number of separate operations and instruments needed while maintaining high detection sensitivity.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The testing system is designed with universal applicability to detect multiple different pathogens using the same basic platform. Different pathogen detection protocols can be run on the same device through software configuration, eliminating the need for separate specialized equipment for each pathogen type.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Productivity

If manual pooling and deconstruction workflows are used in NAT, then high-throughput screening is achieved, but error rates and operational costs increase

Engineering Contradiction:

Improvescreening throughputVSAvoiderror rate

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

Manual mechanical pooling and deconstruction operations are replaced with automated liquid handling systems. Robots and automated dispensers perform sample pooling and distribution, eliminating human error in these repetitive tasks while maintaining high throughput capability.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system performs automatic sample tracking, pooling, and deconstruction without requiring manual intervention. The automated workflow manages its own operations including sample identification, pool creation, and result attribution, reducing operational errors and improving reliability.

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

This approach significantly reduces the time and cost associated with NAT, enhances throughput, and minimizes errors by enabling rapid and sensitive detection of pathogens, thereby optimizing the screening process for blood and plasma release.

Implementation Method 1

using techniques such as isothermal nucleic acid amplification reactions

Methodology Applied

Scientific EffectIsothermal nucleic acid amplification: Nucleation

Implementation Method 2

optical or digital detection

Methodology Applied

Scientific EffectOptical detection: Absorption Spectroscopy

Data Source

PatentUS20240279749A1High throughput nucleic acid testing of biological samples

Publication Date: 2024.08.22 ABBOTT LAB INC

AI summary

The presently disclosed subject matter relates to methods for rapid, sensitive, and high-throughput nucleic acid testing of biological samples, e.g., blood, serum, or plasma samples from donors, as well as systems capable of performing such high-throughput nucleic acid testing.