Immunoassay Cuvettes with Diffusely Bound Reagents
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Solution Overview
Problem
Bench top immunoassay analyzers face challenges in accommodating multi-analyte capabilities and storage of diverse reagents, requiring flexible and compact systems that maintain reagent stability and reduce complexity, while also considering limited bench space.
Innovation Solution
The development of immunoassay cuvettes with a transparent front wall, back wall, side walls, and top opening, featuring non-porous surfaces with diffusely and non-diffusely bound reagents, allowing for one-step or two-step sequential binding assays, enabling unitized consumables that keep reagents in a dry format, reducing storage needs and enhancing stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple reagent vials are stored in the instrument to offer a full menu of assays, then assay availability is improved, but instrument size and complexity increase
Solution Approach 1:
The patent merges multiple reagents and assay components into a single unitized consumable device. The cuvette integrates capture reagents, signal reagents, and assay components in one compact unit, eliminating the need for multiple separate reagent vials and complex fluid handling systems. This consolidation maintains full assay menu availability while significantly reducing instrument complexity and size.
Solution Approach 2:
The unitized consumable device serves multiple functions: it contains capture reagents for antigen/antibody binding, signal reagents for detection, and serves as the reaction vessel. This multi-functional design replaces the need for separate reagent storage compartments, dispensing mechanisms, and reaction chambers, thereby reducing overall instrument complexity while maintaining versatility.
2Reliability
If reagents are stored in refrigerated chambers to ensure long term stability, then reagent stability is improved, but storage space requirements increase
Solution Approach 1:
The reagents are pre-formulated and stabilized in their final assay-ready state within the unitized consumable device during manufacturing. Quality control and stabilization steps are completed in advance, allowing the reagents to remain stable at ambient temperature throughout storage and transport. This preliminary action eliminates the need for prolonged refrigerated storage while maintaining reagent stability and reliability.
Solution Approach 2:
The patent employs parameter changes in reagent formulation, including adjustments in pH, ionic strength, and addition of stabilizing agents, to optimize reagent stability at ambient temperature. These formulation changes allow reagents to maintain their functional properties without requiring refrigeration, thereby reducing storage space requirements while ensuring long term stability.
3Area of stationary object
If unitized consumables are used to reduce instrument size, then device footprint is improved, but reagent accessibility and fluid handling complexity increase
Solution Approach 1:
The unitized consumable device is designed to be self-contained with all necessary reagents and components already integrated. The device performs self-alignment and self-contained fluid management, eliminating the need for complex external fluid handling subsystems. This self-service approach reduces instrument footprint while simplifying operation to basic sample loading and reading.
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 immunoassay cuvettes provide a compact, stable, and flexible solution for performing multiple assays with improved reagent stability and reduced instrument size, allowing for efficient fluid management and detection, while minimizing reagent interference and denaturation.
Implementation Method 1
The back wall of the cuvette has a substantially planar surface made of a non-porous material and comprises a capture zone and a signal reagent zone
Implementation Method 2
The signal reagent zone having one or more spots diffusely bound with a signal reagent
Data Source
AI summary
The present invention is directed immunoassay cuvettes that comprise diffusely bound and non-diffusely bound reagents for carrying out an immunoassay. The reaction and detection are carried out in the immunoassay cuvette. The immunoassay cuvette comprises a transparent front wall, a back wall, side walls, a bottom, and a top opening. The back wall of the cuvette has a substantially planar surface made of a non-porous material and comprises a capture zone having reagents non-diffusedly bound and a signal reagent zone having reagents diffusedly bound.