Single-Sample Macroarray Immunometric Testing With Image Alignment

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Solution Overview

Problem

Existing immunometric test apparatuses are limited to medium/large analytic routines and lack flexibility for small sample analyses, particularly when performing macroarray tests.

Innovation Solution

An apparatus that performs macroarray tests using ready-to-use diagnostic devices for single determinations, incorporating a control unit to process images of reaction wells containing a matrix of analysis points, allowing for automatic recognition and processing of biomarkers, and includes features for virtual alignment and calibration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If ninety-six-well plates are used for macroarray tests, then automation capability is improved, but flexibility for small sample analysis deteriorates

Engineering Contradiction:
Improveautomation capabilityVSAvoidflexibility for small sample analysis
Core Design Contradiction:
Extent of automationVSAdaptability or versatility

Solution Approach 1:

The invention divides the traditional 96-well plate into multiple independent single-well reaction chambers within a single test device. Each chamber can independently perform a complete immunometric test, enabling automated processing while maintaining flexibility for small sample sizes. The segmentation allows the system to handle both single samples and multiple samples without requiring full plate utilization.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent implements a nested structure where multiple reaction chambers are integrated within a single test device housing. The reaction chambers, reagent reservoirs, and detection components are nested together in a compact configuration, allowing the device to function as a complete automated testing unit while occupying minimal space and requiring minimal sample volume.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Quantity of substance

If multiple wells are used for macroarray tests, then measurement capacity is improved, but device complexity deteriorates

Engineering Contradiction:
Improvemeasurement capacityVSAvoiddevice complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The invention merges multiple functional components into a single integrated test device: multiple reaction chambers, reagent storage, sample introduction system, and detection mechanisms are combined into one unit. This consolidation maintains the measurement capacity to analyze multiple biomarkers simultaneously while reducing the overall device complexity compared to using separate wells or plates.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The test device is designed with multi-functionality, where a single device can perform complete immunometric tests for multiple different biomarkers through its array of reaction chambers. Each chamber can be configured for different analytes, allowing the device to universally handle various diagnostic tests without requiring separate specialized equipment for each measurement.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Ease of operation

If single-use test devices are used, then ease of operation is improved, but productivity deteriorates

Engineering Contradiction:
Improveease of operationVSAvoidproductivity
Core Design Contradiction:
Ease of operationVSProductivity

Solution Approach 1:

The single-use test devices are prepared in advance with pre-loaded reagents, pre-coated reaction chambers, and pre-configured detection systems. This preliminary preparation eliminates the need for complex setup procedures during operation, making the system extremely easy to use while maintaining high productivity through automated processing of multiple chambers simultaneously within each device.

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

Enables efficient and flexible performance of macroarray tests on a single sample without the need for multiple wells, providing rapid and accurate results for autoimmune disease biomarkers.

Implementation Method 1

the above-mentioned immune reaction is used together with enzymatic reactions to produce a colored signal that can be easily measured in a quantitative way with appropriate detectors

Methodology Applied
Scientific EffectEnzymatic reaction: Enzyme

Data Source

PatentUS20250362293A1Apparatus for performing immunometric tests
Publication Date: 2025.11.27 DIESSE DIAGNOSTICA SENESE
  • US20250362293A1 patent drawing
  • US20250362293A1 patent drawing
  • US20250362293A1 patent drawing

AI summary

An apparatus for performing immunometric tests is described. The apparatus includes a housing element which receives and allows tests on a single use-type for a single sample test device, a reaction well containing a solid phase, a plurality of wells for reagents, a well for a sample to be analyzed, a control unit for managing the apparatus, and an image detector for acquiring images of the reaction well in communication with the control unit. The control unit processes the acquired images and performs a macroarray test relative to the sample in the test device. During processing, the control unit identifies at the reaction well of the test device, points of a matrix that includes points of analysis related to a specific biomarker that represent measurement parameters of the macroarray test, and performs the macroarray test on the basis of the points. A corresponding method and use procedure are also disclosed.