Unitized Reagent Strip With Cored Hole Tip Detection
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Solution Overview
Problem
Current methods for sample preparation in automated diagnostic assays and high throughput screening face challenges such as manual variability, cross-contamination, and the need for multiple reagent handling, which affect consistency and accuracy.
Innovation Solution
A unitized reagent strip with integrated pipette sheaths, process tubes, and reagent tubes that minimizes cross-contamination and user manipulation, featuring cored holes for detecting pipette tip presence and facilitating quality control, and a laminated layer for reagent storage, allowing for automated detection and efficient sample processing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple separate reagents and disposables are used for sample preparation, then flexibility for different assay requirements is improved, but inter-assay variability and cross-contamination increase
Solution Approach 1:
The patent combines multiple reagents and disposables into a single integrated cartridge that includes all necessary components (reagents, tips, barriers) pre-assembled together. This merging eliminates the need for separate handling of multiple components while maintaining assay-specific configurations, thereby reducing variability and contamination risk without sacrificing flexibility.
Solution Approach 2:
The cartridge is segmented into distinct functional zones with physical barriers separating different reagent compartments and tip storage areas. This segmentation allows each assay type to have its dedicated confined space while preventing cross-contamination between different assay components, resolving the contradiction between versatility and reliability.
2Ease of operation
If manual pipetting operations are performed, then flexibility for different reagent handling is improved, but cross-contamination and human error increase
Solution Approach 1:
The cartridge is designed as a self-contained unit where all pipetting operations are performed using tips that are pre-loaded and pre-barriered within the cartridge structure. The system serves itself by eliminating the need for external manual pipetting, with all fluid handling occurring through integrated tips that cannot contact external surfaces or other samples, thus preventing cross-contamination while maintaining operational flexibility.
Solution Approach 2:
A physical barrier (membrane or filter) acts as an intermediary between the tip interior and exterior environments. This barrier allows the tip to perform its function of transferring fluids while preventing any direct contact between the sample/reagent and external contaminants or surfaces, eliminating cross-contamination risk without restricting the tip's operational capabilities.
3Quantity of substance
If multiple transfer operations are performed, then completeness of sample preparation is improved, but time consumption and labor intensity increase
Solution Approach 1:
All necessary pipette tips and barriers are pre-assembled and pre-positioned within the cartridge before use. The multi-tip holder is pre-configured with the exact number and arrangement of tips needed for the specific assay protocol. This preliminary preparation eliminates the need for sequential manual assembly and transfer operations during the actual assay, completing all necessary transfers in a single automated loading action while ensuring completeness.
4Adaptability or versatility
If separate reagent handling is performed, then adaptability to different vendors and lots is improved, but assay variability increases
Solution Approach 1:
Multiple reagents from different vendors or lots can be merged into a single integrated cartridge with each reagent contained in its own sealed compartment. This allows the system to accommodate vendor and lot variations while ensuring that once combined in the cartridge, all reagents are handled uniformly through the same automated process, eliminating variability introduced by separate handling while maintaining the flexibility to use different suppliers.
Data Source
Figure 1A
Figure 1B
Figure 1C~1E
AI summary
The invention provides a method of detecting the presence or absence of a pipette tip within a pipette sheath of a unitized reagent strip, comprising: providing the unitized reagent strip, the unitized reagent strip, comprising: a strip with a top side and a bottom side, comprising: a first and a second pipette sheath comprising opposing sides, the first and second pipette sheaths comprising a first and second pipette tip aperture, respectively, each of which comprises a separate opening on the top side of the strip, wherein the first and second pipette tip apertures are configured for insertion of a first and second pipette tip into the first and second pipette sheaths, respectively, and wherein each of the first and second pipette sheaths is configured to substantially surround the length of a first and second pipette tip, respectively, and wherein the first pipette sheath comprises a first cored hole, the first cored hole extending through a sidewall of the first pipette sheath; a process tube; and a receptacle, comprising an opening through the reagent strip, wherein the receptacle is configured to receive a reagent tube; determining whether a pipette tip extends within the first pipette sheath from the pipette tip aperture at least to the distance of the first cored hole.