Disposable Cartridge for Rapid Nucleic Acid Detection

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Solution Overview

Problem

Current nucleic acid detection and genotyping methods, such as RT-PCR and RT-LAMP, are time-consuming and require multiple steps, leading to delayed results in diagnostic testing, especially in non-lab settings like homes or retail premises, where rapid detection of pathogens like COVID and Strep-A is critical.

Innovation Solution

A method involving a disposable cartridge with prefilled chambers for sample processing, where a biological sample is lysed in a high pH buffer, mixed with dilution and mastermix buffers, and then directly transferred to an analysis unit for PCR or LAMP amplification, reducing the number of processing steps and time required for nucleic acid detection and genotyping.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional RT-PCR or RT-LAMP amplification methods are used for nucleic acid detection, then detection sensitivity is improved, but processing time increases significantly

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

Solution Approach 1:

The cartridge is pre-filled with all necessary reagents (lysis buffer, dilution buffer, mastermix) in separate chambers before use. This preliminary preparation eliminates the need for time-consuming setup and multiple transfer steps during actual sample processing, reducing total processing time while maintaining detection sensitivity

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The sample processing is divided into distinct functional chambers (lysis chamber, sample chamber, mastermix chamber, analysis chamber) within the cartridge. Each chamber performs a specific function, allowing parallel preparation and reducing sequential processing time while maintaining the integrity and sensitivity of the detection process

Inventive Principle:
Principle #1Segmentation

2Measurement precision

If multiple intermediate steps (washing, elution, nucleic acid capture) are performed during sample preparation, then nucleic acid purity is improved, but processing time and device complexity increase

Engineering Contradiction:
Improvenucleic acid purityVSAvoidnumber of processing steps
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

Multiple traditional processing steps (lysis, washing, elution, nucleic acid capture) are merged into a single integrated cartridge system with pre-filled chambers. The buffers and reagents are combined in specific sequences within the cartridge, eliminating the need for separate washing and elution steps while maintaining nucleic acid purity through the designed buffer compositions and chamber configurations

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The complex multi-step washing and elution process is extracted and replaced by a simplified single-step lysis followed by direct mixing with mastermix. The cartridge design removes unnecessary intermediate steps while preserving the essential function of nucleic acid purification through the optimized buffer system

Inventive Principle:
Principle #2Taking out (Extraction)

3Measurement precision

If traditional multi-step sample preparation methods are used, then nucleic acid detection accuracy is improved, but ease of operation in non-lab settings deteriorates

Engineering Contradiction:
Improvedetection accuracyVSAvoidoperational simplicity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The cartridge is designed as a self-contained, self-service system with all reagents pre-filled and chamber connections pre-established. The user simply needs to insert the sample and cartridge into the device, and the system automatically performs the processing sequence without requiring the user to manually perform washing, elution, or reagent addition steps, making it easy to operate in non-lab settings while maintaining detection accuracy

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

All complex preparation work is performed in advance during cartridge manufacturing - reagents are pre-filled, chamber connections are pre-established, and processing protocols are pre-programmed. This preliminary action transforms a complex multi-step laboratory procedure into a simple plug-and-play operation suitable for non-lab environments

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 significantly reduces sample preparation time from 15 minutes to 1.5 minutes, enabling rapid nucleic acid detection and genotyping, making it suitable for non-medical environments and reducing cross-infection risks, while eliminating the need for intermediate washing steps and toxic reagents.

Implementation Method 1

introducing said sample into a discrete container that is prefilled with a lysis buffer and agitating the container to assist with lysing to release nucleic acid

Methodology Applied
Scientific EffectLysis: Decomposition (biological)

Data Source

PatentUS12024739B1Method and apparatus for rapid analysis of a biological sample
Publication Date: 2024.07.02 DNANUDGE LTD
  • US12024739B1 patent drawing
  • US12024739B1 patent drawing
  • US12024739B1 patent drawing

AI summary

A method of analysing a sample comprising nucleic acid. The method includes introducing the sample into a discrete container that is prefilled with a lysis buffer. Agitating the container to assist with lysing to release nucleic acid. Extracting a lysed sample from the container and introducing the lysed sample into a sample chamber of a disposable cartridge. Mixing the lysed sample with a dilution buffer in the sample chamber to obtain a first mixture. Fluidly connecting the sample chamber to a mixing chamber. “Displacing the first mixture from the sample chamber to the mixing chamber. Fluidly connecting the mixing chamber to a mastermix chamber containing a mastermix. Displacing the first mixture to obtain a second mixture.” Displacing the second mixture from the mastermix chamber to an analysis unit. Operating the analysis unit to identify the nucleic acid or other nucleic acids derived from the nucleic acid.