Microscope Slides with Adjacent Control Samples for Staining Validation
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Solution Overview
Problem
Current automated immunostaining technologies face issues with incorrect dispensing of staining solutions and incomplete tissue coverage due to air bubbles or thick tissue sections, leading to false negatives and non-uniform staining, with existing quality control methods unable to validate complete and uniform staining of tissue samples on microscope slides.
Innovation Solution
Microscope slides with positive and negative control samples positioned adjacent to the tissue sample-affixing area, allowing for real-time confirmation of staining quality through detection of biomarkers, ensuring complete and uniform staining by indicating any staining failures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automated immunostaining technology is used to increase throughput, then productivity is improved, but staining quality control deteriorates due to inability to detect incomplete coverage and non-uniform staining
Solution Approach 1:
The patent applies preliminary action by pre-positioning control tissue sections on the slide at multiple locations before the actual staining process. These control sections are strategically placed to cover the entire staining area, allowing the staining system to be validated in advance without affecting patient sample analysis. This enables quality control to be built into the workflow before patient samples are processed.
Solution Approach 2:
The patent implements local quality by placing control tissue sections at multiple specific locations across the slide (e.g., corners, edges, center) rather than using a single batch control. Each location provides localized quality verification, ensuring that staining is uniform across the entire staining area. This spatial distribution of controls allows detection of location-specific staining defects.
2Device complexity
If batch controls are used for quality control, then device complexity is reduced, but measurement precision deteriorates due to inability to identify staining defects on individual slides
Solution Approach 1:
The patent applies segmentation by dividing the quality control function into multiple spatially distributed control sections across the slide. Instead of a single batch control, control tissue sections are placed at multiple locations (corners, edges, center) to segment the staining area into zones that can be independently validated. This segmentation enables precise localization of staining defects to specific areas of the slide.
Solution Approach 2:
The patent merges the quality control function with the sample analysis slide by incorporating control tissue sections directly onto the same slide as patient samples. This integration eliminates the need for separate control slides while maintaining the ability to detect staining defects. The control and sample sections share the same staining environment, providing more accurate quality assurance.
3Manufacturing precision
If control sections are placed at a single location on the slide, then manufacturing precision is simplified, but reliability deteriorates due to inability to validate complete staining coverage across the entire sample area
Solution Approach 1:
The patent transitions from single-point control to multi-dimensional spatial distribution of control sections. Control tissue sections are placed at multiple locations across the slide surface (corners, edges, center), creating a two-dimensional network of control points. This spatial distribution across multiple dimensions enables comprehensive validation of staining coverage throughout the entire staining area, not just at one location.
Data Source
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AI summary
The present invention provides a microscope slide for analyzing a tissue sample. The slide includes an elongate planar substrate, which comprises a first major surface having a sample-affixing area within which a tissue sample may be affixed; a first positive control sample affixed on the first major surface at a first location adjacent to the sample-affixing area; and a second positive control sample affixed on the first major surface at a second location adjacent to the sample-affixing area. The first and second locations are spaced such that quality of the staining of the first and second positive control samples is indicative of the quality of the staining of the tissue sample. Also provided are a kit containing the microscope slide and a method of making and a method of using the microscope slide.