Virus Detection Kit Direct Amplification Without Purification

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Solution Overview

Problem

Current methods for detecting viruses in biological samples require prior purification or dilution to prevent enzyme inhibition, leading to time-consuming and costly processes, especially during high-throughput testing like pandemics, which can result in backlogs and reduced sensitivity.

Innovation Solution

A method and kit that allow direct amplification of target nucleic acids from virus-inactivated biological samples without prior purification, using virus-deactivating substances that do not compromise amplification reactions, enabling rapid and safe detection of viruses like SARS-CoV-2 in respiratory samples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If prior purification of nucleic acid is performed to remove contaminants, then amplification sensitivity is improved, but processing time and operational complexity increase significantly

Engineering Contradiction:
Improvedetection sensitivityVSAvoidprocessing time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The invention extracts and removes the harmful contaminants (inhibitors) from the biological sample through a simplified purification step that retains the target nucleic acid while eliminating substances that interfere with amplification, thereby achieving sensitivity without requiring time-consuming complete purification protocols

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention performs preliminary inactivation of the virus and removal of inhibitors before the amplification step, preparing the sample in advance so that the subsequent detection can proceed directly without requiring extensive purification during the diagnostic process

Inventive Principle:
Principle #10Preliminary action

2Reliability

If aggressive virus inactivation substances are used to ensure safety, then virus inactivation is improved, but amplification reactions are inhibited

Engineering Contradiction:
Improvevirus inactivation effectivenessVSAvoidamplification sensitivity
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The invention uses the virus inactivation substance to simultaneously achieve two goals: inactivating the virus for safety and creating conditions favorable for amplification. The controlled use of the aggressive substance converts its potentially harmful inhibitory effect into a beneficial dual-function reagent that ensures both safety and detection sensitivity

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The invention optimizes the concentration and composition parameters of the virus inactivation substance to find the optimal balance point where sufficient virus inactivation occurs while the inhibitory effect on amplification is minimized or eliminated, thereby resolving the contradiction between safety and sensitivity

Inventive Principle:
Principle #35Parameter changes

3Object-generated harmful factors

If dilution of biological sample is performed to reduce inhibitor concentration, then interference with amplification is reduced, but detection sensitivity decreases

Engineering Contradiction:
Improveinhibitor interferenceVSAvoiddetection sensitivity
Core Design Contradiction:
Object-generated harmful factorsVSMeasurement precision

Solution Approach 1:

Instead of diluting the sample, the invention selectively extracts and removes the harmful inhibitor substances while retaining the target nucleic acid at its original concentration, thereby reducing interference without compromising detection sensitivity through dilution

Inventive Principle:
Principle #2Taking out (Extraction)

4Measurement precision

If multiple processing steps including purification are used to ensure accurate detection, then detection accuracy is improved, but throughput and productivity decrease

Engineering Contradiction:
Improvedetection accuracyVSAvoidsample throughput
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The invention merges multiple functions into a single integrated reagent system that simultaneously inactivates the virus, removes inhibitors, and preserves amplification efficiency, thereby eliminating the need for separate purification steps and significantly increasing sample throughput while maintaining detection accuracy

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The virus inactivation substance is designed to perform multiple functions: virus inactivation, inhibitor removal, and amplification preservation, making it a universal reagent that replaces multiple separate processing steps and enables high-throughput processing without compromising accuracy

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 simplifies the workflow by eliminating the need for nucleic acid purification, maintaining sensitivity, and reducing processing time, making it suitable for high-volume virus detection during pandemics while ensuring safe handling and effective virus inactivation.

Implementation Method 1

effective virus inactivation using amplification compatible virus-deactivating substances

Methodology Applied
Scientific EffectVirus inactivation:

Implementation Method 2

amplifying at least one target nucleic acid derived from the virus

Methodology Applied
Scientific EffectNucleic acid amplification:

Data Source

PatentUS20230374575A1Method for virus detection
Publication Date: 2023.11.23 QIAGEN GMBH
  • US20230374575A1 patent drawing
  • US20230374575A1 patent drawing
  • US20230374575A1 patent drawing

AI summary

The present invention provides methods and kits for virus inactivation by virus-deactivating substances and direct amplification-based detection of target nucleic acids and viruses in biological samples without prior target purification.