Reusable Linearity Control Slides for Image-Based Hematology Analyzers
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Solution Overview
Problem
There is a lack of commercially available linearity kits suitable for validating the linearity claims of image-based hematology analyzers, such as the cobas® m 511, which are time-consuming, costly, and dependent on technical expertise, resulting in a truncated reportable range and limited accuracy.
Innovation Solution
Development of linearity control slides prepared from specialized blood products, which are stable for at least six months and can be used repeatedly to verify the linearity of image-based hematology systems, spanning the entire analytical measuring interval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional linearity verification methods are used, then linearity can be verified, but the process is time-consuming and costly
Solution Approach 1:
The patent applies preliminary action by pre-preparing linearity control slides with known concentration gradients of blood components before actual verification is needed. These slides are manufactured in advance with precise cell concentrations, eliminating the need to perform time-consuming manual dilution series during verification. The pre-prepared slides can be stored and used repeatedly for linearity verification across multiple analyzers.
Solution Approach 2:
The patent uses copying by creating standardized linearity control slides that replicate the essential features of patient samples but with known, controlled concentrations. Instead of using actual patient samples or performing complex manual preparations each time, the invention creates copy slides that contain predetermined concentrations of blood cells, allowing rapid verification without repeating the entire sample preparation process.
2Reliability
If conventional linearity verification methods are used, then linearity can be verified, but the cost is high
Solution Approach 1:
The patent reduces cost through preliminary action by manufacturing linearity control slides in advance with precise concentration gradients. This eliminates the need to purchase expensive commercial linearity kits or perform repeated manual sample preparations. The pre-prepared slides can be used across multiple analyzers and verification events, amortizing the initial manufacturing cost over many uses.
Solution Approach 2:
The patent applies discarding and recovering by allowing linearity control slides to be used repeatedly across multiple analyzers and verification events. Instead of consuming expensive materials for each verification, the standardized slides can be imaged on different systems, and the same slide can serve multiple purposes, recovering value from each slide through repeated use.
3Reliability
If conventional linearity verification methods are used, then verification can be performed, but technical expertise is required
Solution Approach 1:
The patent improves ease of operation through copying by creating standardized linearity control slides with pre-established concentration gradients. Instead of requiring operators to perform complex manual dilution series or interpret variable patient samples, the invention provides copy slides with known, controlled concentrations that simplify the verification process to loading and imaging the pre-prepared slides.
Solution Approach 2:
The patent applies parameter changes by transforming the verification process from one requiring manual manipulation of sample concentrations to one using pre-fixed concentration parameters in the control slides. The slides contain predetermined cell concentrations that eliminate the need for operators to calculate or adjust dilution factors, reducing the technical expertise required.
4Adaptability or versatility
If the reportable range is extended, then more measurements can be captured, but verification becomes more complex
Solution Approach 1:
The patent applies segmentation by dividing the extended reportable range into discrete concentration levels within the linearity control slides. Each slide contains multiple fields with different known concentrations of blood components, allowing verification across the full reportable range to be broken down into manageable, pre-segmented concentration points that can be verified systematically.
Solution Approach 2:
The patent uses universality by creating linearity control slides that can verify the extended reportable range across multiple analyzers and different blood components simultaneously. A single slide design can be used for WBC, RBC, and platelet verification, and the same slides can be imaged on different cobas analyzers, reducing verification complexity through multi-functional utility.
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 linearity control slides provide reproducible results, reduce costs and time, and ensure accurate linearity verification across multiple systems, detecting optical variances and reducing the need for technical expertise.
Implementation Method 1
staining comprises an eosin solution
Implementation Method 2
staining comprises a methylene blue solution
Data Source
Figure 1~2
Figure 3~4A
Figure 4B~5A
AI summary
The present disclosure provides methods and compositions for preparing linearity control slides to verify linearity of image-based hematology analyzers without the need to make such control slides over and over again for each analyzer each time the analyzer is verified.