Accuracy Management Slide for Automatic Immunostaining Fault Diagnosis

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Solution Overview

Problem

Existing automatic immunostaining devices face challenges in determining the type of abnormality when an issue occurs, requiring manual inspections that are labor-intensive.

Innovation Solution

An accuracy management slide with specific spots (antigen (-), fixation (-)/antigen (+), and fixation (+)/antigen (+)) to check for abnormalities and estimate their causes by analyzing color patterns.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a simple accuracy management slide with one binding substance spot and one non-binding substance spot is used, then the device complexity is reduced, but the measurement precision of abnormality detection deteriorates because the type of abnormality cannot be determined

Engineering Contradiction:
Improvestructure complexity of accuracy management slideVSAvoidabnormality detection precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The accuracy management slide is segmented into multiple functional spots: a non-binding substance spot (antigen (-)), a binding substance spot without fixation (antigen (+), fixation (-)), and a binding substance spot with fixation (antigen (+), fixation (+)). Each spot serves as an independent diagnostic element that provides specific information about different process steps, enabling precise abnormality classification while maintaining simple overall structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different spots on the slide are given different local qualities by varying the presence of binding substances and fixation treatments. This creates a gradient of diagnostic capabilities across the slide, where each spot's specific combination of binding substance and fixation status provides unique diagnostic information about particular immunostaining process steps.

Inventive Principle:
Principle #3Local quality

2Reliability

If manual inspection by user and periodic inspection by engineer are performed, then the reliability of abnormality detection is improved, but the loss of time and productivity deteriorates due to increased workload

Engineering Contradiction:
Improveabnormality detection reliabilityVSAvoidinspection time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The accuracy management slide performs self-diagnosis by visually indicating the status of different immunostaining process steps through color development patterns. The slide automatically provides diagnostic information about binding substance function and fixation effectiveness, eliminating the need for complex manual inspection procedures and reducing both time and expertise requirements for abnormality detection.

Inventive Principle:
Principle #25Self-service

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 the detection of abnormalities and their causes in automatic immunostaining devices, ensuring the process proceeds normally and allowing for timely corrective actions.

Implementation Method 1

The staining technique is used for detecting a specific antigen expressed in a specimen with an antibody reagent. Since localization of the antigen to be examined is visualized, immunostaining is an extremely important technique in pathological examination.

Methodology Applied
Scientific EffectImmunostaining:

Implementation Method 2

When the spot containing a binding substance develops a color and the spot not containing the binding substance does not develop a color, it can be determined that the automatic immunostaining device is normally working.

Methodology Applied
Scientific EffectColor development:

Data Source

PatentEP4644861A1Accuracy management slide, and method using same for inspecting automatic immunostaining device
Publication Date: 2025.11.05 HITACHI HIGH TECH CORP
  • EP4644861A1 patent drawingFigure 1~3
  • EP4644861A1 patent drawingFigure 4(a)~5
  • EP4644861A1 patent drawingFigure 6

AI summary

Provided is an accuracy management slide that can check the presence or absence of an abnormality in an automatic immunostaining device and estimate a cause of the abnormality if occurs. The slide includes a spot (antigen (-)) not containing an antigen); a spot (fixation (-)/antigen (+)) having no histological fixation applied and containing an antigen; and a spot (fixation (+)/antigen (+)) having histological fixation applied and containing an antigen.